FDA Warns Canadian API Manufacturer
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last month to Quebec-based Les Produits Chimiques B.G.R., Inc. listing two observations of significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (APIs).FDA found, according to the warning letter sent 24 July, that the firm distributed multiple lots of a powder without completing required release testing for identity. The company retrospectively tested lots identified during FDA’s inspection, but it did not test all distributed lots within expiry, the warning letter says.
Failures of the company’s quality unit also are detailed in the letter. FDA found the unit failed to ensure “that samples intended for stability studies are stored with controlled temperature and humidity” and failed to ensure that the “records it reviewed included complete data derived from all tests conducted to ensure compliance with established specifications and standards prior to the distribution of an API batch.”
FDA also said the firm’s response did not provide enough detail or evidence that proposed corrective actions and preventive actions (CAPAs) will bring the site’s operations into compliance with CGMP.
Les Produits Chimiques B.G.R., Inc. 7/24/18