Recordkeeping Issues Cited in Form 483 for Belcher Pharmaceuticals

Recordkeeping and reporting issues were cited multiple times in a Form 483 received by Belcher Pharmaceuticals.

The FDA listed nine observations from the April inspection, including that Belcher failed to qualify the laboratory analytical instruments used for the testing of in-process, finished product and stability samples for all products. Belcher also did not have established and documented records and did not establish the accuracy and specificity of test methods.

In addition, Belcher was cited for a failure of a batch or any of its components to meet specifications. In addition, the facility did not always include the conclusions and follow-up to investigations on the failure of a batch of drugs.