FDA 483 - JCB Laboratories LLC - December 03, 2015

The FDA Form 483 inspection revealed significant deficiencies at an outsourcing facility manufacturing pharmaceutical products.

**Laboratory Controls and Testing:** * The facility lacks validated strength testing methods for all finished pharmaceutical products, despite manufacturing various types. This impacts the final release of products.

**Master Production and Control Records:** * **Betamethasone Sodium Phosphate Injectable 6 mg/ml solution:** Batch records are incomplete, not specifying if a specific tool can be used in a step, not recording the amount of a substance, and not following a procedure regarding vial handling (procedure says "vials," but they "the vials"). Check fill volumes are not recorded prior to aseptic filling. * **Lidocaine Jelly (multi-API product):** Batch records lack detailed mixing instructions (e.g., no time requirement or instructions on how to "mix"). Check fill volumes are not recorded prior to filling. This product has 5 batches with documented sub-potency issues (DEV-2015-122, -123, -306).

**Failure Investigation:** * A thorough review of batch failures is lacking. For DEV-2015-306 (sub-potent Lidocaine Jelly batch), no CAPA was planned beyond monitoring trends. "Potential human error" was cited without justification. The investigation failed to identify or discuss unvalidated manufacturing/strength testing methods, identify a root cause, or initiate a CAP