Inspection Record

Novel Laboratories, Inc. d.b.a Lupin Somerset — FDA 483 Findings

US FDAInspected 2026-04-17Published 2026-07-27 3 findingsDeviation, CAPA, and investigationMaterial and supplier controlQuality unit oversight

Inspectors Anthony J Donato · Daniel T LeeThe inspectors who signed the published document.Inspector lookup

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

Findings

1Deviation, CAPA, and investigation

Investigations of an unexplained discrepancy anda failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.

2Material and supplier control

The number of containers to be sampled and amount of material taken from each container is not based upon appropriate criteria.

3Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not fully followed.

About this record

Extracted automatically from the document US FDA published on 2026-07-27. 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

2022-03-30 · US FDA · 12 findings
Novel Laboratories, Inc. d.b.a Lupin Somerset findings history — including this company's other documents US FDA documents, 2026 Go to Findings search