Prescription Labs Inc dba Greenpark – FDA 483, Oct 27, 2017
On October 27, 2017, the FDA issued a Form 483 to Prescription Labs, Inc. dba Greenpark Compounding Pharmacy, located at 4061 Bellaire Blvd., Houston, TX 77025-1121, following an inspection from October 16-20, 23-24, and 27, 2017. The firm is a producer of sterile and non-sterile drugs.
The inspection revealed six observations related to aseptic processing and quality control:
1. **Aseptic Processing Personnel:** On October 17, 2017, an operator performing aseptic processing was observed with partially exposed skin on their upper torso inside the ISO 5 area, while wearing a non-sterile mask, goggles, and hairnet. 2. **Gloved Hand Sanitization:** On October 17, 2017, an operator sanitized gloved hands with non-sterile solution before resuming aseptic processing in the ISO 5 area. 3. **Disinfecting Wipes:** Wipes used for disinfecting the interior of the ISO 5 hood were not sterile. 4. **ISO 5 Area Certification:** The ISO 5 classified areas were not certified under dynamic conditions, specifically, unidirectional air flow was not verified under operational conditions. 5. **Sterility Testing:** There was no evidence of
ID · 0d525240-a35e-4253-a840-800ed02c84bd
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