Inspection Record

Well Care Discount Pharmacy, LLC — FDA 483 Findings

US FDAInspected 2018-07-20Published 2024-01-17 3 findingsOther quality systemMaterial and supplier controlLaboratory and QC controls

Inspectors Ashar P ParikhThe inspectors who signed the published document.Inspector lookup

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

Findings

1Other quality system

Drug products failing to meet established specifications are not rejected.

2Material and supplier control

Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.

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.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. 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.

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