Vann Healthcare Services Inc – FDA 483, Sep 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-