Firm Record

Boothwyn Pharmacy LLC findings history

34 findings from 5 inspection documents published by regulators. Each row below says what its date means.

US FDA 2024-01-17 ~ 2026-02-10 5 documents 34 findings

Areas cited

Aseptic processing and sterility assuranceEquipment and facilityTraining and personnelOther quality systemValidation and qualificationLaboratory and QC controlsStability and storageContamination controlMaterial and supplier controlDeviation, CAPA, and investigationQuality unit oversightEnvironmental monitoring

Published inspection documents

2026-02-10 US FDA 5 findingsAseptic processing and sterility assurance · Equipment and facility · Environmental monitoring Regarding the repeat deficiencies identified in your smoke studies, your firm indicated that new smoke studies were performed on 07/30/2025 using protocols (b)(4) and (b)(4) . However, you did not provide copies of these protocols and the corresponding new smoke studies. Without this supporting documentation, your firm’s assertion that the new smoke studies demonstrate and reflect the following corrective actions cannot be verified: a. “Updated smoke studies will clearly… 2025-08-07 US FDA 5 findingsOther quality system · Aseptic processing and sterility assurance · Equipment and facility Drug held under environmental conditions whereby it may have been rendered injurious to health. 2025-02-12 US FDA 5 findingsMaterial and supplier control · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Laboratory and QC controls · Quality unit oversight Repo1is ofanalysis from component suppliers are accepted in lieu oftesting each component for conformity with all appropriate written specifications, without establishing the reliability ofthe supplier's analyses through appropriate validation ofthe supplier's test results at appropriate intervals. 2024-02-29 US FDA 9 findingsAseptic processing and sterility assurance · Training and personnel · Equipment and facility · Validation and qualification · Contamination control The use of sporicidal agents in the cleanrooms and ISO 5 classified aseptic processing area was inadequate. 2024-01-17 US FDA 10 findingsAseptic processing and sterility assurance · Stability and storage · Equipment and facility Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not 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 Boothwyn Pharmacy LLC — including inspection classifications Browse by document Go to Findings search