What are FDA's Expectations from Contract Manufacturers?

In a four-page Warning Letter to a contract manufacturer who produces semi-solid OTC products, the FDA criticized amongst others:

  • Missing tests of starting and finished products
  • Lacking supplier qualification
  • Non-existent CAPA measures with regard to a wrong primary packaging

Besides, further critics addressed a non-existent programme for Ongoing Process Verification and lacking first validation (Process Performance Qualification).

FDA's statements on the responsibilities of a contractor are particularly interesting. For the FDA, contractors are an "extension" of the actual manufacturer. Regardless of agreements with the products' owner, the contractor is responsible for the quality of products, FDA says.  

The Chinese manufacturer argued to be a cosmetics manufacturer with no intention of manufacturing any drug products. The FDA countered this argument with the definition of a drug product ... The FDA urgently recommended engaging a consultant and explicitly mentioned that the company has to comply with the CGMP anyway. According to the FDA, the executive management remains responsible for complying with CGMP and fully resolving all deficiencies.

Please also read the complete FDA Warning Letter to Hangzhou Karic Commodities Co., Ltd.

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