Inspection Record

Expert Compounding Pharmacy — FDA 483 Findings

US FDAInspected 2022-03-04Published 2022-09-27 5 findingsLaboratory and QC controlsDocumentation and recordsContamination controlMaterial and supplier control

Inspectors Christopher R CzajkaThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Laboratory 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.

2Documentation 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.

3Contamination control

You produced hazardous drugs without providing adequate cleaning of utensils to prevent cross-contamination.

4Material and supplier control

You used a non-pharmaceutical grade component in the formulation of a drug product.

5Contamination control

Non-microbial contamination was observed in your production area.

About this record

Extracted automatically from the document US FDA published on 2022-09-27. 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.

Other records for this company

2022-03-04 · US FDA · 5 findings
Expert Compounding Pharmacy company profile — full history US FDA documents, 2022 Go to Findings search