Drug manufacturer Gordon Laboratories received a Form 483 from the FDA for labeling problems, written procedure issues and insufficient analyses of raw materials.
FDA’s inspection of Gordon’s Upper Darby, Pennsylvania, facility, conducted in January, found the facility failed to appropriately validate the certificates of analysis for incoming raw materials, including active ingredients.
According to the inspectors, the facility failed to test enough batches of each product to determine appropriate expiration dates, and the facility lacked written procedures for production and process controls to ensure product purity, strength, quality and identity.
The inspection also found problems with the facility’s recordkeeping. Batch records did not include distinctive identification numbers identifying major equipment used in the batch manufacturing process. The facility also failed to adhere to written component approval procedures, with several raw materials stored in production areas without required labels identifying them as approved.