1Labeling and packaging
The container of your outsourcing facility's drug products does not include information required by section 503B(a)(10)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Inspection Record
Denver Solutions LLC dba Leiters Health — FDA 483 Findings
Inspectors Taichun QinThe 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
The written stability testing program is not followed.
3Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
4Labeling and packaging
The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Drug and Cosmetic Act (FD&C Act).
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been aheady distributed.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
7Equipment and facility
Written procedures are not followed 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 2024-07-12. 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.
