FDA 483 - Brown's Compounding Center, Inc. - April 27, 2015

The FDA inspection of an outsourcing facility revealed multiple deficiencies in its production, process controls, and quality systems.

**Facility and Operations:** The facility compounds various drug products, including Papaverine HCL, testosterone cypionate, hydroxyprogesterone, lipolean, methylcobalamin, fentanyl, hydromorphone, fentanyl/bupivacaine, phenylephrine, norepinephrine, magnesium sulfate, and dimethyl sulfoxide/dimethyl sulfone.

**Violations and Observations:**

* **Lack of Written Procedures:** No written procedures exist for production and process controls to ensure drug product identity, strength, quality, and purity. Specifically, Papaverine HCL 30 mg/ml stock solution was frozen and re-thawed four times despite refrigeration instructions, with no assurance of stability after reuse. There are no established procedures for the use and manufacture of sterile stock solutions. * **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products are not established. Post-production testing was not conducted on equipment used for 16 lots of aqueous and oil/aqueous drug products. * **Product Release Testing:** Testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory conformance to final specifications. A visual inspection of Lipolean lot 02242015-185607 was not performed with a contrasting white/black background as required, and the SOP did not reference this. No