Firm Record

US Compounding Inc. findings history

33 findings from 4 inspection documents published by regulators. Each row below says what its date means.

US FDA 2019-04-30 ~ 2024-01-17 4 documents 33 findings

Areas cited

Aseptic processing and sterility assuranceLaboratory and QC controlsLabeling and packagingEquipment and facilityDeviation, CAPA, and investigationQuality unit oversightProcess validationRegulatory reporting and change controlStability and storageContamination controlMaterial and supplier control

Published inspection documents

2024-01-17 US FDA 5 findingsQuality unit oversight · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility The quality control unit lacks the responsibility and authority to reject all drug products . 2024-01-17 US FDA 10 findingsRegulatory reporting and change control · Process validation · Aseptic processing and sterility assurance · Stability and storage · Laboratory and QC controls · Labeling and packaging Your outsourcing facility has not submitted a report to FDA identifying product produced during the previous s months as required by section 503B(bX2XA). 2024-01-17 US FDA 8 findingsLaboratory and QC controls · Aseptic processing and sterility assurance · Labeling and packaging · Equipment and facility · Contamination control Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release. 2019-04-30 US FDA 10 findingsMaterial and supplier control · Aseptic processing and sterility assurance · Labeling and packaging · Quality unit oversight · Laboratory and QC controls · Deviation, CAPA, and investigation Repo1ts of analysis from component suppliers are accepted in lieu of testing each component for confo1mity with all appropriate written specifications, without perfo1ming at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

About this page

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.

What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.

Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.

Full history of US Compounding Inc. — including inspection classifications Browse by document Go to Findings search