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

Source: https://www.keypedia.com/records/483/rx-south-dba-rx3-compounding-pharmacy-llc/233d54f7-974a-4eb3-bc6a-e4144c9ec919

> FDA 483 for RX South DBA RX3 Compounding Pharmacy LLC on December 14, 2012. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RX South DBA RX3 Compounding Pharmacy LLC
- Inspection Date: 2012-12-14
- Product Type: Drugs
- Office Name: Baltimore District Office
- Summary: 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

## Related Documents

- [WARNING_LETTER - 2014-02-21](https://www.keypedia.com/records/warning_letter/rx-south-dba-rx3-compounding-pharmacy-llc/63e61349-be63-4f48-ab08-818bb0610256)
- [483 - 2014-02-21](https://www.keypedia.com/records/483/rx-south-dba-rx3-compounding-pharmacy-llc/4c1aa36c-33e2-4c79-9629-78f4e3f4993e)
- [483 - 2016-04-18](https://www.keypedia.com/records/483/rx-south-dba-rx3-compounding-pharmacy-llc/69e7f373-3c66-416e-a2f6-eeee5b8289b6)
- [483 - 2016-04-18](https://www.keypedia.com/records/483/rx-south-dba-rx3-compounding-pharmacy-llc/55370891-1813-4cd6-9a7f-d265faf887d4)
- [STATE_REFERRAL_LETTER - 2016-04-14](https://www.keypedia.com/records/state_referral_letter/rx-south-dba-rx3-compounding-pharmacy-llc/eb36e7e8-cd1a-4070-8daf-2cf2f689a2ca)

## Related Officers

- [Senior Advisor](https://www.keypedia.com/people/rachel-c-harrington/254a4217-8cd8-4a79-bf24-9345d34d0550)

Company: https://www.keypedia.com/companies/rx-south-dba-rx3-compounding-pharmacy-llc/8f0ecc10-47c4-4fcc-8183-ff45b79eb24d

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa