Pentec Health – FDA 483, Apr 1, 2013

The FDA Form 483 details numerous deficiencies at a facility processing injectable drug products, observed between March 18-19, 2013.

**Key Violations and Observations:**

* **Sterilization and Aseptic Processing:** Procedures for preventing microbiological contamination lacked adequate sterilization process validation. Aseptic techniques were deficient, with personnel exhibiting exposed skin (face, neck, forearms) inside ISO 5 Laminar Air Flow (LAF) hoods, leaning over open containers, and having exposed facial hair. Disinfection protocols were not followed for reintroducing items into hoods or for initial equipment placement. * **Facility and Equipment Maintenance:** ISO 5 LAF hoods showed whitish residues, dark stains on HEPA filters, and dark splatters on light fixtures. Equipment obstructed airflow. Non-sterile powder dispensing occurred outside ISO 5 hoods. IV bags were stored improperly, with ports exposed. * **Validation and Testing:** No validation records for sterilization steps or media fill studies simulating actual production were available. Sterility unit procedures were incomplete. Sterility and endotoxin testing SOPs were unsigned/unapproved. Finished products were not incubated at correct temperatures. * **Quality Control and Stability:** No written stability program or data existed for various drug products (Proplete IV, Bupivacaine, Morphine, Hydromorphone stock solutions) to support assigned beyond-use dates. * **Investigations:** Out-of-