Carie Boyd Pharmaceuticals LLC – FDA 483, Dec 12, 2014

This FDA Form 483 details multiple deficiencies observed during an inspection of a drug manufacturing facility.

**Facility and Operations:** The facility prepares various drug products, including injectable solutions (e.g., Dehydrated Alcohol 98% Injectable Solution, Testosterone Cypionate, Glutathione, Chorionic Gonadotropin) and pellets (e.g., Testosterone, Estradiol), from bulk non-sterile APIs and excipients. Operations involve ISO 5 and ISO 7 classified areas.

**Violations and Observations:**

* **Personnel Gowning:** Gowning attire for ISO 5/ISO 7 areas is inadequate, consisting of non-sterile scrubs, disposable lab coats, single hair nets, single ear-loop masks, and booties. Exposed skin around eyes, forehead, and neck was observed, and an employee's wrist was exposed between the lab coat sleeve and glove. Sterile gloves were donned inside the ISO 5 hood. * **Environmental Monitoring:** * ISO 5 area environmental monitoring is not performed daily when drug products are prepared, contradicting SOP 3.030. Viable surface samples are taken only bi-weekly, not daily. * Viable air monitoring is only performed bi-annually during room certification. * Operator monitoring (fingertip sampling) is only performed bi-weekly, not daily for each operator in ISO 5 and ISO 7 areas. *