FDA Warning Letter caused by Lab Data Integrity issues

In December 2022, the U.S. FDA issued a Warning Letter to the Brazilian company "Nortec Quimica SA" after having inspected its site in Rio de Janeiro in July 2022.

The significant violations of cGMP regulations for Active Pharmaceutical Ingredients (APIs), which are mentioned in the Warning Letter, are listed as follows:

  • "Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data."
  • "Failure of your quality unit to review batch production records and laboratory control records prior to distribution of an API batch."

Especially, the first observation mentioned in the Warning Letter is related to the lack of Laboratory Data Integrity. It is listed as an example that the firm failed to have "system security and access control over its electronic data and software systems".

The observed findings resulted in a long list of Data Integrity remediation activities and CAPA measurements requested.

Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA recommends engaging a consultant to support the company in aligning their systems with cGMP requirements. Additionally, the U.S. FDA may refuse new applications or supplements listing the company as 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 Nortec Quimica SA.

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