FDA Warning Letter: Testing, Stability Program and Quality Oversight

Recommendation

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter dated July 19, 2022, to an over-the-counter (OTC) drug product manufacturer in Los Angeles. The Warning Letter goes back to an inspection from September 7 to September 9, 2021. Several GMP violations were identified in the area of laboratory testing, stability program, and quality oversight.

Laboratory Testing

According to the FDA, the firm released OTC drug products without testing to ensure they met their identity, purity, strength, and other appropriate quality attributes.

In response to the Form FDA 483, which preceded the Warning Letter, the company did not address how it will ensure appropriate laboratory determination of satisfactory conformance to final specifications. Further, the company did not include sufficient information about the testing procedures, methods, or a detailed description of the tests.

Stability Program

Another FDA finding relates to the stability program. Again, a poor understanding of GMP became evident, as can be seen from the following quote from the Warning Letter: "You explained to our investigators that the contract manufacturer verbally informed you that a two-year expiration date is the appropriate shelf life for these products without conducting stability studies or providing any stability data."

The FDA expects the company to take several actions in this regard, including an assessment and corrective action and preventive action (CAPA) and a detailed risk assessment.

Quality Oversight

According to the FDA, written quality procedures for investigations, CAPA, change control, training, drug product stability, and finished drug product release were not available. Furthermore, batch production records for approximately 20 batches could not be provided.

The FDA considers this to be "a lack of CGMP understanding and [a] lack of adequate quality oversight and control from incoming products to finished product."

Repeat Observations

In a previous inspection in 2018, similar observations were made. Therefore, the FDA considers the executive management oversight and control over the manufacture of drug products as inadequate.

Please read the Warning Letter posted on the FDA's website for the complete list of deficiencies and other aspects that the FDA has addressed (including unapproved new drug violations and misbranded drug violations).