11/12 November 2020
Following FDA´s August 2019 inspection of a Canadian manufacturer of over-the-counter (OTC) drug products, the Agency now issued a Warning Letter due to non-compliance with cGMP.
The FDA inspectors found discrepancies between HMI (human machine interface) data and batch records and practices of operators not following batch instructions. Therefore the agency requires to provide
The agency observed a lack of process validation and, in addition, a lengthy bulk hold time prior to filling drug products without assuring that this practice does not impact the chemical and microbiological quality.
The agency therefore requests
Particles and OOS Results
According to FDA, the company failed to adequately investigate and document the presence of particles in a product. The manufacturer concluded that the particles were from a broken belt on the filling line, and the corrective action (CA) was to reject a number of units of this lot. However, this CA did not expand to cover batches that were previously filled at the same line or a preventative maintenance plan to prevent recurrence of similar incidents. In addition, the company failed to conduct an adequate investigation into an OOS test result for content. The FDA therefore requests to provide