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 in Baddi, Himachal Pradesh, India, underwent inspection from March 19 to 27, 2024, resulting in a 17-page report, dated April 9, 2024.

The inspection identified multiple deficiencies, notably in the quality system. Ten observations were made, with Observation 1 highlighting the failure to review discrepancies and batch failures thoroughly. A Perkin Elmer UV Spectrophotometer underwent inadequate preventive maintenance, leading to its retirement without assessing its impact on previous test results. Batches tested with this faulty instrument were released into the US market, raising concerns about result reliability.

Other observations include:

• Lack of shipping studies for finished products to US markets
• Delays in managing Change Controls
• Inadequate assessment of GxP impact on computerized systems
• Insufficient controls for computer-acquired data
• Improper handling and storage of drug product containers
• Inadequate documentation of analytical results
• Failure to conduct annual visual examination of reserve samples

The detailed report is available as a PDF on the FDA website.