Firm Record

Wells Pharma of Houston LLC findings history

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

US FDA 2023-02-03 ~ 2026-05-27 4 documents 42 findings

Areas cited

Quality unit oversightAseptic processing and sterility assuranceEquipment and facilityLabeling and packagingDeviation, CAPA, and investigationRegulatory reporting and change controlCleaning validationLaboratory and QC controlsStability and storageMaterial and supplier controlEnvironmental monitoring

Published inspection documents

2026-05-27 US FDA 6 findingsLabeling and packaging · Stability and storage · Laboratory and QC controls · Aseptic processing and sterility assurance · Quality unit oversight Strict control is not exercised over labeling issued for use in drug product labeling operations. 2025-11-25 US FDA 25 findingsCleaning validation · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Material and supplier control · Quality unit oversight · Environmental monitoring · Equipment and facility · Labeling and packaging Your response related to your disinfectant efficacy study referenced an existing CAPA for cleaning validation (CV) requirements and you also noted that an updated study was initiated. You noted that the CV study was not completed as expected, so you opened a new CAPA-HOU-025-004 on March 5, 2025. However, the new CAPA appears to focus on preventing cross-contamination from beta-lactam residues but doesn’t address the findings noted by our investigator. 2025-05-07 US FDA 8 findingsDeviation, CAPA, and investigation · Quality unit oversight · Labeling and packaging · Regulatory reporting and change control · Aseptic processing and sterility assurance · Equipment and facility There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. 2023-02-03 US FDA 3 findingsEquipment and facility · Quality unit oversight Routine inspection and checking of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.

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 Wells Pharma of Houston LLC — including inspection classifications Browse by document Go to Findings search