The FDA issued a four-observation warning letter to Pocono Coated Products for violating GMP standards.

An agency inspection in October revealed the company released drug products to customers without conducting final tests to determine if products conformed to specifications.

The FDA collected samples of finished drug products from the company and found that its drug was sub-potent and contained product labeling that was inconsistent with analysis results. Given these findings, all lots of the drug product were recalled.

In addition, the company failed to validate manufacturing process for its drugs and other transdermal products. An FDA analysis demonstrated that the company’s manufacturing process is not capable of consistently delivering products that meet required specifications.

The FDA also revealed that Pocono failed to prepare batch production and control records with complete information related to the production and control of each drug batch.

The records for each drug batch lacked information critical to the manufacturing process, including machine operating parameters, such as the milling, mixing, and drying time ranges, as well as ingredient target ranges, a sampling plan, and other specifications.

The FDA recommended that the company hire a GMP consultant to fix the issues.

The FDA is looking to shed light on the sometimes murky rules governing compounding  operations primarily regulated on the state level, only adhering to USP 797 Pharmaceutical Compounding — Sterile Preparations. If you want to know how these guidances might affect your company, plan on listening to Responding to Compounding Pharmacy Inspections. Order this webinar CD/transcript today and be informed about compounding facility inspections.