1Material and supplier control
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
Inspection Record
Macau-Union Pharmaceutical Limited — FDA 483 Findings
Inspectors Lillian S Wu · Andrew LeThe 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 of drug products.
3Laboratory and QC controls
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
4Documentation and records
Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
5Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
6Material and supplier control
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
7Process validation
Control procedures are not established which monitor the output and validate the performance ofthose manufacturing processes that may be responsible for causing variability in the characteristics of in- process material and the drug product.
8Equipment and facility
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
About this record
Extracted automatically from the document US FDA published on 2026-07-27. 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.
