FDA 483 - JD & SN Inc. - July 21, 2015

This FDA Form 483 details significant deficiencies at a drug compounding facility, impacting quality systems and manufacturing.

**Key Violations and Observations:**

* **Inadequate Investigations (Observation 1):** The firm failed to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results. This includes not setting alert/action levels for microbial counts in cleanrooms (ISO 5, 6, 8), failing to investigate recorded CFU counts, and not identifying trends or conducting root cause analysis. Potency failures for product (b)(4) were not investigated, and only two out of multiple non-conforming lots were recalled. Formula adjustments for (b)(4) preparations were not addressed. * **Deficient Laboratory Testing (Observation 2):** The facility does not conduct endotoxin testing for sterile products, contrary to their own SOP. Sterility testing lacks an official procedure, and several sterile products were not tested. Visual inspection of sterile injectables is not required to be 100%, and particulate matter was observed in solutions. * **Lack of Aseptic Process Control (Observation 3):** There is no written media fill procedure, and the current practice using (b)(4) is inadequate as it doesn't represent challenging production conditions (e.g., non-sterile powders). Personnel aseptic technique certification and recertification practices are not followed, with one technician performing sterile compounding without initial on-site qualification.