1Equipment and facility
Routine calibration ofelectronic equipment is not performed according to a written program designed to·asstrre proper )>erformance.
Inspection Record
Wiley Chemists, Inc. — FDA 483 Findings
Inspectors Erika V. ButlerThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
The identity ofeach component ofa drug product is not verHied by conducting at Jeast one test to verify the identity, using speeific identity teBts if tbey -exist Specifically, Your firm does not perform identiy on active ingredient components used in the finished drug products.
3Complaint and recall handling
The distribution system is deficient in that each Iourt:.drug product cannot be readily determined to facilitate its recall if necessary.
4Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specification and identity and strength of each active ingredient prior to release.
5Process validation
Control procedures are not estabJished which monitor the output and validate the perfonnance ofthose manufacturing processes that may be responsible for causing variability in the charncterjstics of in-process material and the drug product.
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.
