Firm Record

US Specialty Formulations LLC findings history

82 findings from 7 inspection documents published by regulators. Each row below says what its date means.

US FDA 2019-09-30 ~ 2026-02-03 7 documents 82 findings

Areas cited

Laboratory and QC controlsAseptic processing and sterility assuranceEquipment and facilityOther quality systemStability and storageContamination controlDeviation, CAPA, and investigationLabeling and packagingProcess validationTraining and personnelMaterial and supplier controlComputer system validationQuality unit oversightRegulatory reporting and change controlEnvironmental monitoring

Published inspection documents

2026-02-03 US FDA 6 findingsMaterial and supplier control · Aseptic processing and sterility assurance · Quality unit oversight · Stability and storage · Laboratory and QC controls 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. 2024-11-12 US FDA 7 findingsLaboratory and QC controls · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Material and supplier control · Other quality system · Quality unit oversight Reserve samples from representative sample lots or batches of diug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration. 2024-01-17 US FDA 9 findingsEquipment and facility · Aseptic processing and sterility assurance · Process validation · Contamination control · Laboratory and QC controls Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity ofthe drug product. 2024-01-17 US FDA 5 findingsComputer system validation · Training and personnel · Equipment and facility · Laboratory and QC controls · Labeling and packaging Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. 2023-08-08 US FDA 29 findingsContamination control · Stability and storage · Aseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls · Environmental monitoring · Other quality system Your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a)). 2022-09-26 US FDA 15 findingsDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Laboratory and QC controls · Regulatory reporting and change control · Equipment and facility · Contamination control · Labeling and packaging There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. 2019-09-30 US FDA 11 findingsLaboratory and QC controls · Other quality system · Training and personnel · Stability and storage · Computer system validation · Process validation · Labeling and packaging Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.

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 Specialty Formulations LLC — including inspection classifications Browse by document Go to Findings search