FDA 483 - RX South DBA RX3 Compounding Pharmacy LLC - December 14, 2012

The FDA Form 483 details numerous violations concerning the manufacturing of Medi-bolic Booster Injectable and Pyridoxine/Thiamine 100mg/mL/20mg/mL Injectable.

**Key Violations and Observations:**

* **Sterility Testing Deficiencies:** * Lack of routine sterility testing for most lots of both products manufactured prior to 11/5/2012 (only 4 out of 120+ Medi-bolic lots and 4 out of redacted Pyridoxine/Thiamine lots were tested). * Sterility testing procedures did not follow USP Chapter <71> requirements, using only TSB media instead of both FTM and TSB. * **Stability Testing Issues:** * Absence of a written stability testing program to continuously monitor batches on the market. * One Pyridoxine/Thiamine lot (02112008@1748) failed potency/purity specifications at the 60-day time point (88.23% vs. redacted specification), with no investigation conducted. * No analytical data supported the 90-day expiry for Medi-bolic Booster Injectable. * **Product Release and Potency Testing:** * Lack of routine final product potency testing for both injectables; only four lots of each product were tested for identity