1Aseptic processing and sterility assurance
V I Aseptic processing areas are deficient regarding the system for monitoring environmental conditions .
Inspection Record
Millers of Wyckoff, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
The identity of each component of a drug product is not verified by conducting at least one test to verify the identitY, using specific identity tests if they exist.
3Environmental monitoring
There firm's use of disinfecting agents in the cleanroom and ISO 5 areas is inadequate and infrequent.
4Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of s atisfactory conformance to the identity and strength of each active ingredient prior to release.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
