FDA 483 - PharMEDium Services LLC - February 28, 2013

This FDA Form 483 details observations from an inspection, highlighting significant deficiencies in the facility's quality systems and manufacturing processes for sterile drug products.

**Personnel and Gowning:** Observation 1 notes that personnel clothing is inappropriate for sterile drug processing. Operators touch sterile gowns with bare hands during gowning (per procedure CPS-305, 11/30/2012), and gowns are re-used and re-handled during cleanroom exit/re-entry, potentially compromising sterility.

**Laboratory System Deficiencies:** * **Sterility and Endotoxin Testing (Observation 2):** Batches of sterile drug products are not adequately tested for sterility and pyrogen-free requirements. Only 52 of 2012's sterile drug lots were sterility tested, and no endotoxin testing data exists for any sterile drug lots produced from January 2012 to the present. * **Identity and Strength Testing (Observation 3):** Routine identification and potency testing is not performed on most of the firm's 30+ sterile drug products. In 2012, only 12.7% of lots were tested, with 99.3% of that testing restricted to Magnesium Sulfate and Oxytocin. * **Expiration Date Determination (Observation 4):** Expiration dates are not based on site-specific processing conditions. All expiration dates, such as 9