1Equipment and facility
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity ofthe drug product.
Inspection Record
National Prescription Services Inc. dba HRI Pharmacy — FDA 483 Findings
Inspectors Russell K. RileyThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
3Process validation
Control procedures are not established which validate the performance ofthose manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
4Material and supplier control
Reports ofanalysis from component suppliers are accepted in l ieu oftesting each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the r eliability ofthe supplier's analyses through appropriate validation ofthe supplier's test results at appropriate intervals.
5Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory detennination of satisfactory 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.
