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The QMN Weekly Bulletin

FDA Hits Aesica Over Quality Controls, Record-Keeping

April 21, 2017

The FDA has cited contract manufacturer Aesica for quality and record-keeping problems.

The agency issued a Form 483 following a November 2016 inspection of the firm’s Kent, U.K., facility.

The inspectors found the quality management system inadequate and that the facility had no formal change control system.

The agency also flagged the quality assurance department for failing to thoroughly review raw electronic data or audit trails to ensure there was no unreported data and that all data reported was accurate prior to shipment of APIs and bulk finished drug products.

The FDA found the quality assurance unit sometimes used incomplete batch records and that the firm failed to investigate all quality-related complaints.

In addition, the facility did not always properly handle and store materials returned to the warehouse from manufacturing — a repeat observation from a February 2015 inspection.

Aesica did not respond to a request for comment.

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