1Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
Inspection Record
Sincerus Florida, LLC — FDA 483 Findings
Inspectors Jennifer L HuntingtonThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
The in process control procedures were deficient in that they did not include an examination of the adequacy of mixing to assure uniformity and homogeneity.
3Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been aheady distributed.
4Laboratory 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.
5Equipment 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.
6Quality unit oversight
Each lot of components is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. 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.
