ImprimisRx NJ – FDA 483, Sep 30, 2015

On September 30, 2015, the FDA issued a Form 483 to Pharmacy Creations, a producer of sterile drugs located in Randolph, NJ. The inspection, conducted from August 27 to September 30, 2015, identified three observations.

**Observation 1:** The firm failed to adequately test drug product batches to determine appropriate expiration dates. Specifically, non-preserved sterile preparations, such as Bupivacaine Sodium/Lidocaine HCl Bladder and Triamcinolone Solution-Prefilled Syringes, were assigned beyond-use dates of up to 180 days without supporting potency and sterility testing.

**Observation 2:** Deficiencies were noted in the environmental monitoring system for aseptic processing areas. Non-viable particulate monitoring was limited to ISO-5 certification, with no periodic monitoring during aseptic filling of batches, some containing up to 1,000 units. Additionally, daily viable monitoring, including surface, settling plate, and personnel monitoring, was not performed.

**Observation 3:** Procedures to prevent microbiological contamination of sterile drug products were not established, written, or followed. Furthermore, no recovery studies were performed to determine if a known quantity of endotoxin could be recovered from vials. No signed protocol or report was generated for this study, lacking established acceptance criteria, discussion of results, or documentation of deviations. Only laboratory testing results showing passing results for sample vials were provided.