1Contamination control
Non-microbial contamination was observed in your production area.
Inspection Record
Expert Compounding Pharmacy — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
You produced hazardous drugs without providing adequate cleaning of utensils to prevent cross-contamination.
3Laboratory and QC controls
Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of components used in the manufacture, processing, packing, or holding of drug products.
4Material and supplier control
You used a non-pharmaceutical grade component in the formulation of a drug product.
5Documentation and records
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing and processing.
About this record
Extracted automatically from the document US FDA published on 2022-06-24. 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.
