Advanced Pharma Inc. – FDA 483, Jul 22, 2016

The FDA Form 483 documents observations from an inspection of a facility producing sterile drug products. Key deficiencies include the lack of established procedures to prevent microbiological contamination of sterile drug products. Specifically, non-sterile and sterile sanitizers are used for ISO 5 Laminar Air Flow hoods, but the non-sterile sanitizer is not sterilized prior to use, and there is no data to support its sporicidal efficacy.

Media fill process simulations are not conducted under challenging conditions, with a significant portion of the media fill consisting of a single unit type. The firm produced a large lot of Phenylephrine 100mcg/ml in Normal Saline in Syringes (lot #4/22/16 1310 830-61(s)) totaling (b)(4) units.

Test procedures for sterility and pyrogens are not written, and endotoxin testing is not performed for epidural drug products such as Fentanyl (2mcg/ml) and 0.125% Bupivacaine HCl PF in 150ml Bag (lot #6/27/16 1021 21915P) and Morphine Sulfate PF 1mg/ml in 2ml vial (lot #6/29/16 1045 24142EPF), which were distributed.

Suitability testing has not been