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.