Zhejiang Huahai Pharmaceutical Co. Ltd.
Form 483 issued April 24, 2026 · Linhai, China
- Inspection
- Apr 13 – Apr 24, 2026
- Investigators
- Dipesh K. Shah· Eileen A. Liu· Marcellinus D. Dordunoo
- Observations
- 13
- Pages
- 24
- FEI number
- 3003999190
In short: On April 24, 2026, FDA issued a Form 483 with 13 observations to Zhejiang Huahai Pharmaceutical Co. Ltd. in Linhai, China (FEI 3003999190) after an inspection that ran Apr 13 – Apr 24, 2026. The investigators were Dipesh K. Shah, Eileen A. Liu and Marcellinus D. Dordunoo. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and quality system account for 8 of 13 observations.
Most cited: 21 CFR 211.192 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records are not made of investigations into unexplained discrepancies the failure of a batch or…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 04
Laboratory records do not include complete data derived from all tests, examinations, and assay necessary to…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmZhejiang Huahai Pharmaceutical Co. Ltd. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Huahai Pharmaceutical Co. Ltd.?
FDA listed 13 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Zhejiang Huahai Pharmaceutical Co. Ltd.?
Dipesh K. Shah, Eileen A. Liu and Marcellinus D. Dordunoo are named on this Form 483, for the inspection of Apr 13 – Apr 24, 2026. Each investigator has a profile showing what they cite most.
When was Zhejiang Huahai Pharmaceutical Co. Ltd. inspected by FDA?
The inspection ran Apr 13 – Apr 24, 2026, and the Form 483 is dated April 24, 2026.
How do I get the full Form 483 for Zhejiang Huahai Pharmaceutical Co. Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.