FDA 483 - Oakdell Compounding Pharmacy LLC - March 29, 2017
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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.
ID · 0be9dd29-5b30-4e91-b21b-1bffd533fdc8
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