Firm Record

Stokes Healthcare Inc. dba Epicur Pharma findings history

36 findings from 3 inspection documents published by regulators. Each row below says what its date means.

US FDA 2020-12-22 ~ 2025-08-11 3 documents 36 findings

Areas cited

Process validationAseptic processing and sterility assuranceLaboratory and QC controlsDeviation, CAPA, and investigationOther quality systemDocumentation and recordsComplaint and recall handlingEquipment and facilityStability and storageQuality unit oversightEnvironmental monitoring

Published inspection documents

2025-08-11 US FDA 5 findingsAseptic processing and sterility assurance · Laboratory and QC controls · Process validation · Stability and storage Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. 2024-10-22 US FDA 27 findingsDocumentation and records · Aseptic processing and sterility assurance · Other quality system · Laboratory and QC controls · Equipment and facility · Quality unit oversight · Process validation · Deviation, CAPA, and investigation · Environmental monitoring In your response, you provided an executed potency test method validation protocol for your Tacrolimus AQ human drug products; however, this test method remains unvalidated because the validation study: a. Lacked scientific rationale to justify establishing some of the relative standard deviations limits at (b)(4) ; b. Documented significant intra-batch potency variability; c. Did not record chromatography column temperature information for specificity, limit of quantification, limit of detection, linearity, accuracy, precision, intermediate precision, and stability testing; d. Concluded that the analytical results meet all acceptance criteria, although some sample results failed to meet specifications. Additionally, you did not consider the impact of these test method changes on the accuracy of the potency results for all previously distributed batches within expiry. 2020-12-22 US FDA 4 findingsComplaint and recall handling · Deviation, CAPA, and investigation · Process validation Procedures describing the handling of all written and oral complaints regarding a drug product are not established and followed.

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 Stokes Healthcare Inc. dba Epicur Pharma — including inspection classifications Browse by document Go to Findings search