Zhejiang Huahai Pharmaceutical Co. Ltd.
FDA inspection history in Linhai, China, 2016 to 2026
- 5
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2016: one Form 483; 2019: two Form 483s; 2025: one warning letter and one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Linhai, China.
- 2019Two Form 483s, at Linhai, China.
- 2025–26Two Form 483s and one warning letter, at Linhai, China.
- 2026The longest 483 on file: 13 observations over 24 pages at Linhai, China.
Cited most
Across all Zhejiang Huahai Pharmaceutical Co. observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.160General requirements5
- 21 CFR 211.192Production record review5
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.67Equipment cleaning and maintenance3
The complete Zhejiang Huahai Pharmaceutical Co. file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Linhai, China
Five Form 483s · 2016 to 2026 · 35 observations
Latest: Form 483, Apr 24, 2026 →
Also: one document not tied to a site.
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-04-24 | 483 Form 483 | Linhai, China | 13 | $99 |
| 2025-06-06 | Warning letter Warning letter | — | — | $99 |
| 2025-01-24 | 483 Form 483 | Linhai, China | 7 | $99 |
| 2019-06-28 | 483 Form 483 | Linhai, China | 5 | $99 |
| 2019-05-31 | 483 Form 483 | Linhai, China | 6 | $99 |
| 2016-11-18 | 483 Form 483 | Linhai, China | 4 | $99 |
Investigators on these documents
Justin A. Boyd (2)Jonathan W. Chapman (2)Jeffrey P. Raimondi (1)Marcellinus D. Dordunoo (1)Peter E. Baker (1)Dipesh K. Shah (1)Zedong Dong (1)Eileen A. Liu (1)
FEI number 3003999190 · most recent document Apr 24, 2026
About Zhejiang Huahai Pharmaceutical Co. Ltd.
How many FDA Form 483s has Zhejiang Huahai Pharmaceutical Co. Ltd. received?
FDA Intel has 5 Form 483s on file for Zhejiang Huahai Pharmaceutical Co. Ltd.; the most recent is dated Apr 24, 2026.
When was Zhejiang Huahai Pharmaceutical Co. Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Zhejiang Huahai Pharmaceutical Co. Ltd. is a Form 483 dated Apr 24, 2026, for the site in Linhai, China.
What did FDA cite at Zhejiang Huahai Pharmaceutical Co. Ltd.?
The regulations cited most in the observations on file for Zhejiang Huahai Pharmaceutical Co. Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.160 (General requirements), 5 times; 21 CFR 211.192 (Production record review), 5 times.
Has Zhejiang Huahai Pharmaceutical Co. Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Zhejiang Huahai Pharmaceutical Co. Ltd.; the most recent is dated Jun 6, 2025.