# FDA 483 - Oakdell Compounding Pharmacy LLC - March 29, 2017

Source: https://www.keypedia.com/records/483/oakdell-compounding-pharmacy-llc/0be9dd29-5b30-4e91-b21b-1bffd533fdc8

> FDA 483 for Oakdell Compounding Pharmacy LLC on March 29, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oakdell Compounding Pharmacy LLC
- Inspection Date: 2017-03-29
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: On March 29, 2017, the FDA issued a Form 483 to Oakdell Pharmacy LLC in San Antonio, TX (FEI Number 3004497213) following an inspection from March 20-29, 2017. The facility is identified as a producer of sterile and non-sterile drugs.

The inspection revealed two key observations:

1.  **Non-sterile Disinfecting Agents and Wipes:** The firm was observed using non-sterile disinfectants and non-sterile wipes in the ISO 5 laminar flow hood, which is designated for aseptic processing. This directly impacts the sterility of the aseptic processing environment.

2.  **Inadequate Media Fills:**
    *   Media fills were not performed to closely simulate actual aseptic production operations, failing to incorporate worst-case activities and conditions. The firm's procedure, "Validation of Personnel - Sterile Compounding," specified a certain number of vials for media fills, but the actual fills conducted between April 13, 2016, and January 4, 2017, were not representative of typical production processes.
    *   For instance, the firm routinely produces sterile, injectable drug products (e.g., Papaverine HCl, Phentolamine Mesylate, Prostaglandin E1) in larger batch sizes, which were not simulated in the media fills.

## Related Documents

- [STATE_REFERRAL_LETTER - 2017-03-20](https://www.keypedia.com/records/state_referral_letter/oakdell-compounding-pharmacy-llc/2d29f3d0-6b99-43ec-8c0c-3888500049f4)

## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/stephen-d-brown/01ff1439-f6d7-4501-a104-573dae30d306)

Company: https://www.keypedia.com/companies/oakdell-compounding-pharmacy-llc/a70c713f-5d37-478f-bf71-19353394faa9

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9