Firm Record

Zhejiang Huahai Pharmaceutical Co., Ltd. findings history

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

US FDA 2018-08-09 ~ 2026-07-13 5 documents 26 findings

Areas cited

Aseptic processing and sterility assuranceEquipment and facilityLaboratory and QC controlsQuality unit oversightProcess validationDeviation, CAPA, and investigationOther quality systemDocumentation and recordsComplaint and recall handlingCleaning validationComputer system validation

Published inspection documents

2026-07-13 US FDA 9 findingsLaboratory and QC controls · Computer system validation · Equipment and facility · Deviation, CAPA, and investigation · Quality unit oversight · Complaint and recall handling · Aseptic processing and sterility assurance Laboratory records do not include complete data derived from all tests, examinations, and assay necessary to assure compliance with established specifications and standards. 2025-06-17 US FDA 3 findingsAseptic processing and sterility assurance · Process validation · Cleaning validation Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)). You also manufacture (b)(4) drug products used to treat various conditions including (b)(4) . Our investigator observed a 2 cm x 126 cm piece of a non-sterile tape between (b)(4) below the HEPA filters and above the (b)(4)… 2025-05-23 US FDA 6 findingsAseptic processing and sterility assurance · Process validation · Quality unit oversight · Laboratory and QC controls · Equipment and facility Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include adequate validation ofthe &ierilization process. 2025-03-06 US FDA 4 findingsDocumentation and records · Deviation, CAPA, and investigation · Equipment and facility · Quality unit oversight The master batch production record lacks an established time limits and detailed production instructions to ensure 1he quality of intermediates and AP[s are met for individual processing steps and/or total process. 2018-08-09 US FDA 4 findingsAseptic processing and sterility assurance · Equipment and facility · Other quality system · Laboratory and QC controls Written procedures designed to prevent contamination ofdrug 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 Zhejiang Huahai Pharmaceutical Co., Ltd. — including inspection classifications Browse by document Go to Findings search