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 inspection focused on the manufacturing of sterile OTC products and homeopathics as a subcontractor.

Key criticisms from the FDA include:

•  Inadequate protection of the aseptic ISO-5 area, resulting in high-risk manual interventions during batch manufacturing.
•  Poorly protected product contact equipment, leading to exposure to unacceptable environmental conditions.
•  Improperly designed connections risking contamination of sterile tubing.
•  Insufficiently smooth equipment surfaces for proper cleaning and sanitizing.
•  Non-aseptic setup of equipment in contact with the product.
•  Inadequate environmental monitoring, with infrequent surface and personnel monitoring.
•  Lack of routine identification of microorganisms isolated during monitoring.
•  Discrepancies between reported microbiological data and FDA findings.
•  Criticism of employees' behaviour in the cleanroom, including improper handling of sterile equipment and irregular hand disinfection.

Additionally, the FDA noted the company's failure to sterilize equipment directly contacting the sterile product, relying solely on cleaning and disinfection.

The Warning Letter is available on the FDA website for further details.