Inspection Record

Zhejiang Huahai Pharmaceutical Co., Ltd. — FDA 483 Findings

US FDAInspected 2024-11-20Published 2025-03-06 4 findingsDocumentation and recordsDeviation, CAPA, and investigationEquipment and facilityQuality unit oversight

View the regulator's official source The source document is always the basis for judgement.

Findings

1Documentation and records

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.

2Deviation, CAPA, and investigation

Deviation investigation relating to facility, equipment and production are not always investigated.

3Equipment and facility

The procedure for collecting cleaning samples from the manufacturing equipment is deficient.

4Quality unit oversight

Lack ofQuality Unit oversight to ensure integrity oftest data and document management.

About this record

Extracted automatically from the document US FDA published on 2025-03-06. The source is available at the link above.

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.

Translation and classification are automated and may differ in nuance from the source.

Other records for this company

2026-04-24 · US FDA · 9 findings2025-06-17 · US FDA · 3 findings2025-04-16 · US FDA · 6 findings2016-11-18 · US FDA · 4 findings
Zhejiang Huahai Pharmaceutical Co., Ltd. findings history — including this company's other documents US FDA documents, 2025 Go to Findings search