1Other quality system
Drug products are not stored under appropriate conditions of so that their identity, strength, quality, and purity are not affected.
Inspection Record
Unico Holdings, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Written procedures are lacking which describe in sufficient detail the approval of components.
3Quality unit oversight
Drug product production and control records, are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
4Process validation
Written production and process control procedures are not documented at the time of performance.
5Stability and storage
Results of stability testing are not used in determining expiration dates.
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.
