Inspection Record

McAlister Drug Corporation — FDA 483 Findings

US FDAInspected 2019-10-03Published 2020-02-24 4 findingsMaterial and supplier controlStability and storageEquipment and facilityContamination control

Inspectors Shanna N PurdyThe inspectors who signed the published document.Inspector lookup

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

Findings

1Material and supplier control

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

2Stability and storage

There is no written testing program designed to assess the stability characteristics of drug products.

3Equipment and facility

Routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.

4Contamination control

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

About this record

Extracted automatically from the document US FDA published on 2020-02-24. 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.

McAlister Drug Corporation company profile — full history US FDA documents, 2020 Go to Findings search