Inspection Record

US Specialty Formulations LLC — FDA 483 Findings

US FDAInspected 2026-01-14Published 2026-02-03 6 findingsMaterial and supplier controlAseptic processing and sterility assuranceQuality unit oversightStability and storageLaboratory and QC controls

Inspectors Mindy M Chou · Lu ChenThe 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

Certificates of testing of containers and closures are accepted in lieu of testing without establishing the reliability of the supplier's test results through appropriate validation of the test results at appropriate intervals.

2Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.

3Quality unit oversight

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

4Stability and storage

Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.

5Laboratory and QC controls

The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and docu mented.

6Stability and storage

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

About this record

Extracted automatically from the document US FDA published on 2026-02-03. 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

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US Specialty Formulations LLC company profile — full history US FDA documents, 2026 Go to Findings search