1Aseptic processing and sterility assurance
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressfol conditions.
Inspection Record
CD Pharmacy LLC dba Red Rock Pharmacy — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Personnel were observed touching equipment or other surfaces located outside of the ISO S area with gloved hands and then proceeding with aseptic processing without changing or sanitizing gloves.
3Other quality system
Hazardous drugs were produced without providing adequate containment.
4Other quality system
Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
5Aseptic processing and sterility assurance
Smoke studies were inadequately perfomed under dynamic conditions.
6Material and supplier control
Materials were exposed to lower than ISO 5 quality air.
7Aseptic processing and sterility assurance
Personnel were observed conducting aseptic manipulations where the movement of"first air" in tHE ISO 5 area is blocked or disrupted.
8Contamination control
Personnel inadequately sanitized gloves to prevent contamination.
9Other quality system
Inadequate post-use filter-integrity testing on filters used to sterilize drug products.
About this record
Extracted automatically from the document US FDA published on 2026-09-10. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
