1Other quality system
Your firm released drug product in which the strength differs from that which it purports or is represented to possess.
Inspection Record
CFP Acquisitions, Inc — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
There is a lack of routine and rigorous certification of the ISO 5 area, including smoke studies performed under dynamic conditions.
3Material and supplier control
You used a non-pharmaceutical grade component in the formulation of a drug product.
4Aseptic processing and sterility assurance
Media fills were not performed to closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
5Environmental monitoring
Your cleanrooms are outfitted with HEPA filters directly adjacent to the return vent in the ceiling.
About this record
Extracted automatically from the document US FDA published on 2022-05-31. 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.
