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The QMN Weekly Bulletin

FDA Hits Suzhou Amerigen for Inadequate Investigations, Quality Controls

May 5, 2017

The FDA issued a Form 483 to drug manufacturer Amerigen for insufficient record-keeping and quality controls following a November 2016 inspection of the company’s Suzhou, China, facility.

The facility kept inadequate records of investigations into product discrepancies, according to the form. For example, when the company discovered deviations in a product batch, it did not adequately investigate root causes or take corrective actions. The company also failed to properly investigate a discrepancy in batch records discovered in 2015.

FDA also faulted the company’s laboratory controls, which did not use scientifically sound procedures for assuring drug identity, strength, quality and purity standards. For example, the facility’s procedures allowed for invalidating out-of-specification results and retesting with no scientific basis.

Lastly, according to FDA, the facility lacked established control procedures to monitor and validate manufacturing processes that may have caused deviations between the in-process material and the final product. For example, certain facility units had no cleaning and sanitization schedule to prevent microbial contamination.

Know what the investigators look for — before they even get there. Know the investigators’ expectations and rights. Find and fix problems before they end up on a Form 483 or warning letter. Available directly from FDAnews, the newly updated edition of the Investigations Operations Manual 2017 is the primary source FDA investigators use to conduct field inspections.

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