Indian Sterile Facility in a Dilapidated Condition

During an inspection carried out in October 2022, the FDA found unsanitary and dirty conditions at a sterile manufacturer in India, resulting in a Warning Letter.

According to the FDA, the manufacturing facility was in a dilapidated condition and unsuitable for sterile manufacturing. The following are listed as examples:

• Peeling paint on the ceilings of ISO-7 production rooms
• HEPA filter in the manufacturing area covered by a plastic bag, preventing airflow
• Broken tiles along the wall base in the production areas
• Holes in the production areas patched with masking tape

In addition, the FDA has written about production facilities visibly soiled with oil or grease residues. Furthermore, a manual operation uses printer paper taped to the work surface where the products are filled and packaged.

As expected, the FDA considers these conditions unacceptable to maintain a suitable production environment and prevent product contamination. Even if the product is sterilized terminally, it is imperative, according to the FDA, to adequately design and maintain equipment to avoid the risk of particulate contamination, for example.

The Indian manufacturer had admitted in a letter that cleaning and disinfection were inadequate and revised the associated SOPs. However, the FDA lacked a retrospective review and assessment of the risks to product quality, including all potential contamination risks. In addition, the manufacturer failed to establish an adequate cleaning and disinfection program.

The consequences are now the above-mentioned Warning Letter and an import ban in the USA.