API Plant Gets Warning Letter for Repackaging Lapses

An inadequate response to a Form 483 about deviations in current good manufacturing practice (cGMP) led to an FDA warning letter for MD Pharmaceutical Supply’s active pharmaceutical ingredients (API) repackaging and relabeling facility in Hanover, Pa.

The warning letter also noted that temperature probes used to monitor the controlled substances storage area were not operational during the inspection and that the company failed to monitor humidity in the storage area. The agency said it needs to see probe location information, the identity of people monitoring storage conditions and how data will be controlled, maintained and reviewed.

The FDA also rapped the company for performing API repackaging and relabeling in an uncontrolled and open environment, calling for a retrospective assessment to make sure no API cross-contamination or distribution mix-ups occurred.

The company told the agency that it would cease repackaging and labeling operations, but the FDA sought clarification of whether the company planned to resume, transfer or move operations in the future.