1Quality unit oversight
The responsibilities an d procedures applicable to the quality control unit are fully followed.
Inspection Record
Akina Pharmacy — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Cleaning validation
Cleaning procedures have not been validated for effectiveness.
3Laboratory and QC controls
Testing and release of drug products to r distribution do not include appropriate laboratory determination of satisfactory conformance to final specifications of identity and strength of each active ingredient prior to release.
4Equipment and facility
Written procedures are not followed for cleaning and maintenance of equipment, including utensils, used in the man ufacture, processing, packing or holding of a drug product.
5Complaint and recall handling
Firm lacks procedures and written documentation for investigations into complaints and failures.
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.
