# FDA 483 - RX South DBA RX3 Compounding Pharmacy LLC - April 18, 2016

Source: https://www.keypedia.com/records/483/rx-south-dba-rx3-compounding-pharmacy-llc/55370891-1813-4cd6-9a7f-d265faf887d4

> FDA 483 for RX South DBA RX3 Compounding Pharmacy LLC on April 18, 2016. 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: 2016-04-18
- Product Type: Drugs
- Office Name: Baltimore District Office
- Summary: This FDA Form 483 documents observations from an inspection of a facility producing sterile drug products.

**Facility and Operations:** The facility engages in aseptic processing of injectable drug products, including Phenylephrine HCL, IC Rescue Solution, 100% Glycerin Injectable, Testosterone Cypionate (Sesame) 200mg/ml injectable, Methylcobalamin 25mg/ml (PF) injection solution, and Prostaglandin (UD) 500mcg/ml injectable. Operations involve ISO 5 Laminar flow hoods and ISO 7 areas.

**Violations and Observations:**

*   **Aseptic Processing Area Maintenance:** Brown stains were observed on a HEPA filter in an ISO 5 Laminar flow hood, and rusty conditions were noted on the metal support structure beneath an ISO 5 Laminar flow in the IV room.
*   **Cleaning and Disinfection:** Cleaning records from January 1 to March 31, 2016, did not show the use of sporicidal disinfectant in ISO 5 Laminar flow hoods or ISO 7 areas; only sterile disinfectant was documented for ISO 5 hoods.
*   **Sterilization Process Validation:**
    *   The sterilization process for 100% Glycerin Injectable was not validated, despite lots 103240216@31 and 10328201

## 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 - 2012-12-14](https://www.keypedia.com/records/483/rx-south-dba-rx3-compounding-pharmacy-llc/233d54f7-974a-4eb3-bc6a-e4144c9ec919)
- [483 - 2016-04-18](https://www.keypedia.com/records/483/rx-south-dba-rx3-compounding-pharmacy-llc/69e7f373-3c66-416e-a2f6-eeee5b8289b6)
- [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

- [Director](https://www.keypedia.com/people/haijing-hu/28ccb7af-e88f-4009-8b80-dec72a7b4621)
- [Account Director](https://www.keypedia.com/people/stacie-a-woods/75a78a01-422e-4c6a-b7ac-b858354264ae)
- [SVP Consulting & Operations](https://www.keypedia.com/people/linda-f-murphy/a8b9737f-d5f4-4a36-8684-2fb050d008f2)

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