U.S. Warning Letter caused by Data Integrity Failures

In August 2023, the U.S. FDA issued a Warning Letter to the US American company "Cosmobeauti Laboratories & Manufacturing Inc." after having inspected its site in March 2023.

The significant violations of cGMP regulations for drug products, which are mentioned in the Warning Letter, are listed as follows:

  • "Your firm's quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22)."
  • "Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable organisms. Your firm also failed to test an adequate number of batches of each drug product to determine an appropriate expiration date. (21 CFR 211.165(b) and 21 CFR 211.166(b))."
  • "Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess. Your firm also failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.100(a) and 21 CFR 211.188)."

In the Warning Letter it is stated that the company was already inspected by the U.S. FDA in 2017 with similar observations. Now, the repeated findings outline that the Quality oversight and control of the production of the company is not in compliance with the cGMP regulations.
The observed findings resulted in a long list of Data Integrity remediation activities and CAPA measurements requested. Highlights of these listed requirements are mentioned below: 

  • "A comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses."
  • "A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations."
  • "A management strategy for your firm that includes the details of your global CAPA plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to the FDA."

Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA strongly recommends engaging a cGMP consultant to support the company in aligning their systems with cGMP requirements and to do a so called "comprehensive six-system audit". Additionally, the U.S. FDA may withhold issuance of export certificates and refuse new applications listing the company as drug manufacturer until the site has addressed all observations and fully complies with cGMP requirements, which might be checked by a further inspection.

To view the complete list of violations and the conclusion given by the U.S. FDA, please see the Warning Letter Cosmobeauti Laboratories & Manufacturing Inc.

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