FDA 483 - Vann Healthcare Services Inc - September 24, 2014

An FDA Form 483 was issued following an inspection on September 10, 2014, identifying several deficiencies in the facility's operations related to sterile drug product manufacturing.

**Violations and Observations:**

1. **Personnel Clothing:** An operator performing aseptic manipulations in an ISO 5 laminar flow hood wore a non-sterile gown that did not adequately cover wrists or the upper chest, failing to meet appropriate clothing standards for duties.

2. **Sterilization Process Validation:** * Sterilization processes for Lidocaine 4% injectable and Hydroxyprogesterone caproate injection were not validated. * The sterilization process for stoppers used with Hydroxyprogesterone caproate injection 250 mg/ml was not validated. * Media fills were not conducted to validate aseptic processes in the ISO 5 laminar flow hood. * Endotoxin testing was not performed for products sterilized by filtration.

3. **Microbiological Contamination Testing:** No sterility or endotoxin test data existed for Lidocaine 4% injectable (60-day refrigerated BUD), Epinephrine 1:1000 injection (30-day room temperature BUD), or Hydroxyprogesterone caproate injection, 250 mg/ml (90-day room temperature BUD).

4. **Stability Testing Program:** No written program or potency test data supported the assigned beyond-