Bizarre Warning Letter to Chinese Drug Manufacturer

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7/8 May 2024

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Over the past months, the ECA reported about the growing number of warning letters issued to Asian companies. A recent FDA Warning Letter resulted in a ban on imports for a Chinese manufacturer of pharmaceutical products (Bicooya Cosmetics Limited).

What did the FDA inspectors discover? Here are some examples:

• Rodent feces were found throughout the facility, even in direct proximity to the filling lines (violation against 21 CFR 211.56(a)).
• Residue was found in the tanks, a damaged hose was patched up with plastic wrap, a hinge broke when a lid was opened (violation against 21 CFR 211.67 (a)).
• Not all released products were tested for active ingredient content; none of the released products were microbiologically tested (violation against 21 CFR 211.188).
• There were no batch production and control records for goods distributed to the USA. In addition, analytical testing records were missing data, dates and signatures. During the inspection, personnel was observed falsifying data (violation against 21 CFR 211.188).

Because of their complaints, the FDA strongly recommends engaging a consultant as per 21 CFR 211.34. The data manipulations especially had yet again been addressed in the Warning Letter. Here, the FDA recommends an investigation by a third party. One of the demands is interviewing the staff in order to work through the data inaccuracies, for example. These interviews are to be performed with former(!) employees, as well. Furthermore, the FDA demands a risk assessment on the potential risks of the discovered deficiencies in regards to product quality. The risk assessment should also include the patient risk of products, for which data integrity issues exist. The assessment is also to evaluate the risk of recent activities. As a final measure, the FDA demands a management strategy describing details of global CAPA activities. In these CAPA activities, the data integrity problems should also be addressed, once more.

Considering these deficiencies, it is not surprising that the FDA imposed a ban on imports and warned the company that new marketing approvals may not be authorised. In their Warning Letter, the FDA also stressed that Bicooya's answer to the deficiencies had been extremely superficial.

For further details please see the FDA Warning Letter to Bicooya Cosmetics Limited.