FDA 483 - Innovative Compounding Pharmacy - April 17, 2015

The FDA Form 483 documents observations from an inspection of a drug manufacturing facility.

**Facility and Operation Details:** The inspection covered areas involved in aseptic processing, including an ISO-5 LAF hood, ISO-7 anteroom, and buffer room. The facility manufactures sterile injectable products, including Testosterone Cypionate 200mg/ml.

**Violations and Observations:** 1. **Unclean Conditions:** Spatters were observed on the ceiling of the ISO-5 LAF hood on April 13, 2015, despite being logged as clean on April 10, 2015. 2. **Deficient Cleaning/Disinfection:** Non-sterile wipes were used for the ISO-5 LAF hood, and non-sterile, non-lint-free mop-heads were used for ISO-7 areas. Cleaning procedures for the ISO-5 LAF hood lacked detail. No records demonstrated disinfectant solution effectiveness throughout its period of use. 3. **Inadequate Environmental Monitoring:** Viable and non-viable particulate monitoring was never performed during routine aseptic filling. Glove touch plate monitoring was inconsistent. The pressure differential gauge between ISO-7 and unclassified areas was not continuously monitored, alarmed, or calibrated. Only one passageway was monitored. Pressure records from January 13 to April 13, 2015, showed 65% of readings below the required 0.0