Pharmakon Pharmaceuticals, Inc. – FDA 483, Mar 16, 2016

The FDA Form 483 details numerous deficiencies at an unnamed outsourcing facility.

**Observation 1** highlights inadequate testing and release procedures for sterile injectable drug products. Finished lots, including Morphine Sulfate (PF) 0.5mg/ml and Morphine Sulfate 5mg/ml, were released without potency or preservative content testing, respectively. A Morphine Sulfate lot (E52418EV11C) was distributed with 2460% potency and subsequently recalled. Since April 2014, 11 batches were released prior to receiving out-of-specification potency results, and no investigations were conducted. Additionally, no investigations were performed for sterility positive (Midazolam HCl lot EMS3063C) or "Cancelled or Sample Untestable" results (Ephedrine Sulfate, Fentanyl Citrate, and Sodium Citrate lots).

**Observation 3** notes a lack of established and followed procedures to prevent microbiological contamination during aseptic processing. Operators exhibited improper aseptic techniques, such as waving hands to dry sanitizer, not changing gloves after leaving the ISO 5 Suite, resting gowned arms on work surfaces, and blocking first air. Furthermore, aseptic processing validation (media fills) was inadequate, not performed under worst-case conditions, and did not use representative container systems or equipment. This is a repeat observation from a March 13, 2014, FDA 483.

**Observation