1Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Inspection Record
Belmar Pharmacy — 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
2Laboratory and QC controls
The written stability program for drug products does not include reliable, meaningful, and specific test methods.
3Equipment and facility
The building lacks adequate space for the orderly placement ofequipment and materials to prevent mix-ups between drug products and to prevent contamination.
4Aseptic processing and sterility assurance
Each batch of diUg product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
5Laboratory and QC controls
Testing and release ofdiUg product for distribution do not include appropriate laboratory detem1ination of satisfactory conformance to the final specifications and identity and strength ofeach 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.
