1Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
Inspection Record
Davis City Pharmacy Inc. — FDA 483 Findings
Inspectors Patty P Kaewussdangkul · Steven A BrettlerThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Unsealed, loose ceiling tiles were observed in your non-sterile "compounding lab".
3Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
4Contamination control
You produced highly potent drugs without providing adequate containment, segregation, cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
5Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
About this record
Extracted automatically from the document US FDA published on 2022-06-24. 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.
