1Computer system validation
Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
Inspection Record
Arnold Professional Pharmacy — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component or establishing the reliability of the supplier's analy...
3Process validation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
4Laboratory and QC controls
Testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory conformance to formal specifications and 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.
