Vital Care Compounder, Inc – FDA 483, Jul 7, 2016

The FDA Form 483 details numerous deficiencies at a drug manufacturing facility, primarily concerning the absence of a quality control unit and inadequate aseptic processing controls.

**Key Violations and Observations:**

* **No Quality Control Unit:** The firm lacks a quality control unit responsible for approving or rejecting materials and products. A non-patient specific non-sterile oral liquid (C-Chloral Hydrate 100mg/mL) was produced with 10 times the required active ingredient, creating a super-potent product, which was not rejected. Potency testing on finished drug products is not performed, and retain samples are not maintained. * **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products are not established or followed. An employee was observed aseptically processing eye drops in non-sterile gowning, exiting and re-entering the clean room without changing, and failing to wipe down sterile bottles or re-sterilize gloves. * **Facility and Equipment Hygiene:** A scale in the ISO 8 prep room contained white powder residue. Active ingredients from previous processing were also noted. The owner entered the ISO 8 prep room without wiping non-sterile goggles. Open trash receptacles were observed in classified areas, including near ISO 5 Glove Box and hood. * **Sterilization and Depyrogenation Validation:** The firm has not validated the autoclave sterilization process for rubber stoppers and terminally sterilized drug products. The sterilization