Pharma GMP Newsletter

06-10-2024

What Deviations can be found in FDA Warning Letters: Lack of GMP Training and related Documentation

Training in Good Manufacturing Practices (GMP) is essential for employees, specialists, and managers in GMP-regulated manufacturing, forming the foundation of a complia

01-10-2024

Maharashtra FDA took strict action against ayurvedic drug manufacturer for violating DMR Act

The Maharashtra Food and Drugs Administration (FDA) recently raided Gynoveda Femtech Pvt. Ltd., an Ayurvedic drug manufacturer in Bhiwadi, Thane district, seizing drugs

30-09-2024

FDA issued an Updated Guidance for Nitrosamines

In September 2024, the U.S. FDA released Revision 2 of the document titled "Control of Nitrosamine Impurities in Human Drugs." This updated guidance supersedes the prev

30-09-2024

Large Number of Deficiencies at Indian Manufacturer results in Warning Letter

In January 2024, the FDA inspected Eugia Pharma Specialities Limited in Hyderabad and identified several significant deficiencies, resulting in a Warning Letter on Augu

30-09-2024

FDA issues Warning Letter : Cell Gene Therapy manufacturer

In November 2023, the US FDA issued a Warning Letter to CARsgen Therapeutics Corporation, a CAR T cell manufacturer, due to Good Manufacturing Practice (GMP) violations

30-09-2024

FDA criticises Non-Application of SPC (Statistical Process Control) in Validation

In 2011, the FDA introduced updated guidance on process validation, establishing a life cycle that includes Continued Process Verification (CPV) to assess whether proce

26-09-2024

FDA planning to reclassify hepatitis B assays

The FDA plans to reclassify hepatitis B virus (HBV) assays from high-risk class III devices to moderate-risk class II, allowing them to use the 510(k) pathway for appro

24-09-2024

Many FDA-approved AI devices lack validation data

A recent article in *Nature Medicine* reveals that over 40% of artificial intelligence tools approved by the FDA lack clinical evidence. Researchers from the University

20-09-2024

Notified Body Survey on Applications and Certificates under the MD/IVD Regulation

A 2023 EU Commission survey of 39 notified bodies assessed certifications and applications under the Medical Device and In-Vitro Diagnostic Regulations (MDR/IVDR). The

20-09-2024

FDA published Draft Guidance on Human Factor Studies

The U.S. Food and Drug Administration (FDA) has released draft guidance outlining detailed instructions for conducting use-related risk analyses (URRAs) for drugs, biol

19-09-2024

Data quality and integrity concerns, violative lab practices : US FDA issued warning letters to two Chinese firms

The US Food and Drug Administration (FDA) issued warning letters to two Chinese nonclinical testing labs—Mid-Link Testing Company Ltd. in Tianjin and Sanitation &

15-09-2024

FDA issued warning letters on ozone cleaners for CPAP machines

The FDA has issued warning letters to Leel Tech, Natures Pillow, Top Dog Direct, Adventure Innovations, and Shenzhen Moyeah for selling unapproved devices that claim to

11-09-2024

Non-Pharmaceuticals and Pharmaceuticals on the same Equipment

Questions often arise about using pharmaceutical equipment for both drug and non-drug production. The FDA has recently reinforced its stance on this issue in a new Warning Letter.

 Ref

11-09-2024

FDA Perspective on Responsibilities of Quality Assurance

FDA Warning Letters offer insight into CGMP regulations, with a recent letter highlighting deficiencies in quality assurance. The letter cited 21 CFR 211.22, focusing o

11-09-2024

Root Cause Analysis resulted in FDA Warning Letter issuance

After inadequate root cause analyses at Intercos Europe S.p.A. in Italy, which led to an FDA Warning Letter in mid-August, another Warning Letter was issued just days l

11-09-2024

U.S. Manufacturer received FDA Warning Letter for Serious Quality Failures

In August 2024, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to a U.S. manufacturer, Kaylaan LLC, after an inspection uncovered significant viola

10-09-2024

German Authority releases new GDP Non-Compliance Report

The competent authority in Germany (Bezirksregierung Koeln) has issued a new GDP Non-Compliance Report in the EudraGMDP database. A reinspection of a wholesale distribu

04-09-2024

DCA Telangana raids & seizes illegally manufactured cough syrups in Hyderabad

The Central government tightened drug manufacturing standards after Indian-made cough syrups were linked to 66 child deaths in Gambia in 2022. Despite this, illegal syr

03-09-2024

FDA's final Guidance on the Use of eHRs in Clinical Studies: Real-World Data

The FDA has released final guidance on Real-World Data (RWD) as part of its Real-World Evidence (RWE) program. This guidance provides information on using electronic he

02-09-2024

FDA Warning Letter issued to US Manufacturer of non-sterile Drugs

 On July 23, the FDA issued a Warning Letter to Omega Tech Labs LLC in Boise, USA, citing several deficiencies:

1. Wri

02-09-2024

Insufficient Root Cause Analysis results in FDA Warning Letter

Intercos Europe S.p.A. in Italy recently received an FDA Warning Letter due to failures in testing incoming raw materials, investigating deviations, and missing data.

28-08-2024

FDA Warning Letter issued to pharmaceutical Manufacturer in Puerto Rico

Max Chemical Inc., a pharmaceutical OTC product manufacturer in Puerto Rico, received a Warning Letter from the FDA in June due to significant GMP violations. The inspe

21-08-2024

Warning Letter issued to US Company because of Lack of Product and Process Control

 On August 5, the FDA issued a warning letter to LS Promotions Inc. in Hicksville, addressing several CGMP violations. The letter, following the review of the comp

21-08-2024

FDA issues Warning letter to Jordanian OTC drug Manufacturer

The U.S. FDA issued a Warning Letter on July 11, 2024, to a Jordanian OTC drug manufacturer, Nowrez & Ismail Shukri Company, publicly released on August 13, 2024. T

21-08-2024

Visual Inspection of Parenterals: ECA Guidance

Attendees of the ECA Conference on Visual Inspection of Parenterals, scheduled for November 6-7, 2024, in Berlin, Germany, will receive the latest edition of the ECA's

12-08-2024

FDA Issues Warning Letter to Vietnamese Drug Manufacturer due to CGMP Violations

The U.S. FDA issued a Warning Letter to Yahon Enterprise Co., Ltd., a Vietnamese drug manufacturer, after a December 2023 inspection revealed significant CGMP violation

12-08-2024

FDA issued a Warning Letter due to Inadequate Lab Testing Procedures

In August 2024, the U.S. FDA issued a Warning Letter to Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. following an inspection of their site in December 2023.

12-08-2024

FDA Warning Letter issued due to Supplier Qualification

CMO (Contract Manufacturing Organization) supplier qualification and contracts are key focus areas during inspections. The FDA recently issued a Warning Letter to Veloc

12-08-2024

TGA launches shorter Surveillance Inspections

Starting July 1, 2024, the Australian TGA will implement new regulations for GMP inspections of domestic and international manufacturers of medicinal products, APIs, bi

12-08-2024

A next Step for the SoHO (Standards of Quality and Safety for Substances of Human Origin) Regulation

On May 27, 2024, EU member states adopted groundbreaking regulations to enhance the safety and quality of blood, tissues, and cells in healthcare. The SoHO Regulation a

06-08-2024

Issues in Clean Room at Contract Manufacturer of sterile Eye Preparations resulted a warning letter

Optikem International Inc. received a Warning Letter from the FDA for significant issues in aseptic manufacturing and facility conditions. The FDA found the production

05-08-2024

FDA issues warning letter to defibrillator battery manufacturer

The FDA issued a warning to Amco International Manufacturing & Design for continuing to produce and distribute batteries for automated external defibrillators (AEDs

01-08-2024

FDA issues Warning Letters for Selling Products constituting Delta-8 THC

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued Warning Letters to five companies—Hippy Mood, Earthly Hemps, Shamro

31-07-2024

FDA Form 483 issued to Chinese Manufacturer containing some alarming Observations

In January 2024, the FDA conducted an inspection at Jiangsu Hengrui, and the preliminary findings were documented in a Form 483. The FDA criticized Jiangsu Hengrui for

31-07-2024

Report issued on Trends in the Medicines' Falsification

The EU Commission must report to the European Parliament and Council on medicinal product falsification trends within five years of the Falsified Medicines Directive 20

31-07-2024

FDA issues a warning letter and criticizes Water System at Korean Sunscreen Manufacturer

During an inspection of a Korean manufacturer producing OTC sunscreen, Aqualex Co., Ltd., the FDA identified multiple Good Manufacturing Practice (GMP) violations, part

31-07-2024

FDA issues Warning Letter on Data Integrity concerns

On June 18, 2024, the FDA issued a Warning Letter to Dominican company Laboratorio Magnachem International for CGMP violations, following a November 2023 inspection. Th

23-07-2024

FDA Warning Letter issued to Chinese OTC Manufacturer for Lack of Analytical Test Data

On July 8, 2024, the FDA issued a Warning Letter to YangZhou SuXiang Medical Instrument Co., Ltd., a Chinese OTC drug manufacturer. The letter, based on a review of the

23-07-2024

FDA outlines detailed CAPA Procedure in Warning Letter

An FDA Warning Letter notifies a company of regulatory violations observed during an inspection, citing specific laws and requiring corrective actions. A recent letter

23-07-2024

FDA Warning Letter issued to a Manufacturer of an Athlete Muscle Maintenance Crème

On July 9, the FDA issued a Warning Letter to South Korean manufacturer reBom Co., Ltd. for non-compliance with CGMP standards. The letter cites issues found in respons

20-07-2024

GDP Non-Compliance Report for Czech Wholesale Distributor

The State Institute for Drug Control in Czechia has published its first GDP Non-Compliance Report for 2024 in the EudraGMDP database. Dated June 27, 2024, the report fo

19-07-2024

FDA Warning Letter issued due to Missing incoming Control Tests

In June 2024, the U.S. FDA issued a Warning Letter to Portuguese company Fancystage Unipessoal, LDA, following a January 2024 inspection. The letter highlights serious

06-07-2024

World Health Organization releases updated laboratory biosecurity guidance

The World Health Organization (WHO) has updated guidance for national authorities and biomedical labs on managing biological risks.

03-07-2024

FDA publishes Final Rule on Medical Gases

The U.S. FDA has implemented a new rule mandating certification for medical gases and updating GMP requirements, safety reporting, and labeling. Collaborating with stak

01-07-2024

FDA Warning Letter: GMP Requirements also applicable to HPLC Analyses for Internal Use

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to GFA Production Xiamen Co., Ltd., a Chinese drug manufacturing facility, for significant CGMP viol

22-06-2024

World Health Organization releases warning on falsified medicines used for diabetes treatment and weight loss

The World Health Organization (WHO) has issued a global alert regarding falsified semaglutide medications used to treat type 2 diabetes and obesity in several countries

12-06-2024

GMP Problems with critical Medicinal Products - what next?

A recent non-compliance statement by the Malta Medicines Authority reveals that Akriti Pharmaceuticals, an Indian company, fails to meet Good Manufacturing Practice (GM

07-06-2024

CDSCO publishes new draft guidance on pharmacovigilance requirements for vaccines

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance for the pharmaceutical industry on pharmacovigilance requirements for human vaccin

05-06-2024

Handling of Microbiological Deviations and Sterility Testing - FDA issues Warning Letter

A few years ago, following nearly 800 meningitis cases linked to the New England Compounding Center, the FDA intensified scrutiny of compounding facilities, resulting i

29-05-2024

FDA issued a Warning Letter to Contract Testing Laboratory in Uruguay following Data Integrity Violations

The FDA issued a Warning Letter on April 30, 2024, to a Montevideo-based contract testing lab following a November 20-22, 2023 inspection. Violations of Current Good Ma

15-05-2024

Lack of Quality Oversight: EU Non-Compliance Report issued to Omeprazole Manufacturer

The Norwegian Medical Products Agency issued a recent EU Non-Compliance Report to Everest Organics Limited in India, a manufacturer of Omeprazole, citing 18 deficiencie

15-05-2024

FDA Warning Letter with multiple Deviations to a Korean Company

On April 16, the FDA issued another Warning Letter to Korean manufacturer C&T Dream Co., Ltd. regarding their production of over-the-counter topical medicines, foll

08-05-2024

FDA Warning Letter: Missing Identification Tests

In March 2024, Master Paints & Chemicals Corp. received a Warning Letter from the U.S. FDA following an inspection in October 2023. The letter outlined significant

08-05-2024

Cardinal receives FDA warning letter because of unapproved syringes

Cardinal Health received an FDA warning letter on April 24 for selling convenience kits containing piston syringes not FDA authorized. Violations were discovered during

02-05-2024

WHO: Draft for the Prevention and Control of Nitrosamine Contamination

The World Health Organization (WHO) has released a new preliminary guideline outlining considerations for preventing and managing nitrosamine contamination in pharmaceu

30-04-2024

FDA issued a Warning Letter to a Biotechnology Company in China

In April 2024, the FDA issued a Warning Letter to Jiangsu Meifan Biotechnology Co Ltd, a Chinese OTC drug manufacturer, citing significant Good Manufacturing Practice (

30-04-2024

Warning letter issued to South Korea - from process validation to analysis of starting and raw materials

The FDA issued a Warning Letter to FirstCham Co, Ltd., citing violations of CGMP guidelines found during an October 2023 inspection. Key findings include:

24-04-2024

Missing Ongoing Stability Studies for APIs : FDA Warning Letter

In April 2024, the U.S. FDA issued a Warning Letter concerning Antaria Pty. Ltd., an Australian company, following an inspection conducted in November 2023.

The

22-04-2024

FDA Form 483 mentions 10 Observations made during an Inspection of an Indian Drug Manufacturer

The FDA issues Form 483, listing inspection observations, some of which are posted on their website. Alkem Laboratories Limited, a drug manufacturer

15-04-2024

FDA issues Warning Letter to Canadian OTC Manufacturer

A Canadian OTC drug manufacturer received a Warning Letter from the U.S. FDA for significant violations of CGMP regulations. The firm produces hand sanitizer gel and bu

09-04-2024

Beckman Coulter receives FDA warning letter

The warning letter identifies the DxI 9000 Access Immunoassay analyzer instrument system and its assays as the items deemed "adulterated" due to compliance shortcomings

03-04-2024

Warning Letter issued to Chinese OTC Manufacturer: Violations of Current Good Manufacturing Practice (CGMP) regulations

On March 26, 2024, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to a Chinese manufacturer operating a U.S.-registered facility, known for produci

03-04-2024

Inadequate Equipment and Facility Design

The FDA issued a Warning Letter to Amman Pharmaceutical Industries, a Jordanian manufacturer, after finding significant violations during an August 2023 inspection. The

31-03-2024

Indian Sterile Facility in a Dilapidated Condition

In October 2022, Madhu Instruments Private Limited in India received a Warning Letter from the FDA due to unsanitary conditions discovered during an inspection. Issues

29-03-2024

FDA issued a warning letter for reprocessed medical devices: Renovo

Renovo specializes in reprocessing and cleaning medical devices like Depuy Mitek Ablation Wands and Ethicon Bladeless Trocars. While holding multiple 510(k) c

25-03-2024

FDA Warning Letter to Drug Manufacturing Facility in Thailand

The U.S. Food and Drug Administration (FDA) issued a Warning Letter on February 27, 2024, to a drug manufacturing facility in Thailand for serious violations of Current

25-03-2024

EU Non-Compliance Report issued after insufficient CAPA

A recent EU Non-Compliance Report issued by the Maltese Medicines Authority to Cubit Lifesciences in India highlights significant observations, necessitating a detailed

21-03-2024

FDA sends three warning letters in probe of plastic syringes made in China

In late 2023, the FDA commenced evaluating plastic syringes from China for quality issues, advising against their use due to reported problems. Warning letters were issued to Medline Industries and

15-03-2024

EMA/FDA joint Q&As on Quality and GMP aspects of Breakthrough Therapy Applications

The FDA and the European Medicines Agency (EMA) have jointly published "EMA–FDA joint Q&As on Quality and GMP aspects," aiming to support quality enhancement

15-03-2024

Exactech drilled with a warning letter over implant packaging

The FDA issued a warning letter to Exactech regarding packaging issues with its orthopaedic implants, potentially hastening device degradation. Exactech, a manufacturer

15-03-2024

FDA warning letter over issues at ex-Ivenix site: Fresenius Kabi

Fresenius Kabi received a warning letter related to large-volume infusion pumps acquired through its $240 million takeover of Ivenix. The FDA cited delays in completing

09-03-2024

FDA Warning Letter on unapproved and misbranded Drugs

On February 7, 2024, the FDA issued a Warning Letter to a company based in the United States, US Chem Labs. The letter addresses the marketing and distribution of

06-03-2024

Non-compliance Report (EudraGMDP): Cross-Contamination Risk at Indian Pharmaceutical Company

Following an inspection of Saga Lifesciences Limited, an Indian pharmaceutical manufacturer, the Maltese authority issued a non-compliance report. This inspection serve

22-02-2024

Telangana and Goa regulators qualified to observe US FDA inspections in India

The US Food and Drug Administration (FDA) announced that Goa and Telangana's regulatory bodies can now observe inspections conducted by the FDA in India. These states j

20-02-2024

CDSCO issues regulatory policies for sampling of drugs, cosmetics and medical devices

The Central Drugs Standard Control Organisation (CDSCO) has issued final regulatory guidelines to streamline sampling procedures and maintain a centralized database. Th

20-02-2024

KMIO framing complete state childhood cancer policy to place it as a national guideline

The Kidwai Memorial Institute of Oncology (KMIO) in Karnataka is crafting a comprehensive childhood cancer policy for the state, aspiring to set a national standard for

20-02-2024

Parliamentary Panel advises revision of MAI, PLI strategies to boost pharma exports

The Commerce Parliamentary Standing Committee proposed revisions to the Market Access Initiative (MAI) guidelines to support large enterprises and recommended adjusting

19-02-2024

A new FDA Warning Letter for Chinese Company after the Review of Records

We recently covered a Warning Letter issued to a Chinese manufacturer for significant breaches of cGMP regulations concerning finished pharmaceuticals. The U.S. Food an

14-02-2024

FDA Warning Letter states about observation of particulates in repackaged drug components

In January 2024, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Glicerinas Industriales, S.A. de C.V., a Mexican company, following a May 2023 i

09-02-2024

WHO: Updated Edition of the GMP Compendium for Medical Products

The World Health Organization (WHO) has published the 10th edition of the "Quality Assurance of Pharmaceuticals: a Compendium of Guidelines and Related Materials, Volum

09-02-2024

ICMR issues extensive guidance on ethical prerequisites for laboratory validation testing

The Indian Council of Medical Research (ICMR) has recently issued detailed guidelines titled "Ethical Requirements for Laboratory Validation Testing" to uphold ethical

08-02-2024

FDA Revision to the Guidelines on Quality Considerations for Ophthalmic Drug Products

FDA has updated its guidance on Quality Considerations for Ophthalmic Drug Products in response to recent incidents of microbial contamination and safety recalls. The r

07-02-2024

India's Health Ministry modifies GMP Rules - and replaces the 'GMP' Term.

The Indian pharmaceutical industry, a major exporter of generic drugs, faces scrutiny for occasional lapses in quality. In response, the Ministry of Health has issued r

07-02-2024

New FDA Warning Letter for inadequate Quality Oversight

The FDA issued a Warning Letter to a pharmaceutical company in Thailand for breaching current Good Manufacturing Practice (CGMP) regulations. The letter cited numerous