Zhejiang Huahai Pharmaceutical Co., Ltd.
FDA inspection history across 2 sites, 2017 to 2024
- 3
- Form 483s
- 1
- Close-out
- 1
- EIR
Every document, by year
- Form 483
- Close-out
- EIR
2017: one Form 483; 2018: one close-out letter, one inspection report and one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–18Two Form 483s, one close-out letter and one inspection report, at Dugiao, China and Linhai, China.
- 2018The longest 483 on file: 11 observations over 11 pages at Linhai, China.
- 2024One Form 483, at Linhai, China.
Cited most
Across all Zhejiang Huahai Pharmaceutical Co. observations on file
- 21 CFR 211.192Production record review7
- 21 CFR 211.67Equipment cleaning and maintenance5
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.160General requirements3
- 21 CFR 211.22Responsibilities of quality control unit3
The complete Zhejiang Huahai Pharmaceutical Co. file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Linhai, China
Two Form 483s and one inspection report · 2018 to 2024 · 19 observations
Latest: Form 483, Nov 20, 2024 →Dugiao, China
One Form 483 · 2017 · 1 observation
Latest: Form 483, May 19, 2017 →
Also: one document not tied to a site.
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-20 | 483 Form 483 | Linhai, China | 8 | $99 |
| 2018-11-29 | Close-out Close-out letter | — | — | $99 |
| 2018-08-21 | EIR EIR | Linhai, China | — | $550 |
| 2018-08-03 | 483 Form 483 | Linhai, China | 11 | $99 |
| 2017-05-19 | 483 Form 483 | Dugiao, China | 1 | $99 |
Investigators on these documents
Cheryl Clausen (2)Joel D. Hustedt (2)Alan A. Rivera (1)Massoud Motamed (1)Pratik S. Upadhyay (1)
FEI number 3003885745 · most recent document Nov 20, 2024
About Zhejiang Huahai Pharmaceutical Co., Ltd.
How many FDA Form 483s has Zhejiang Huahai Pharmaceutical Co., Ltd. received?
FDA Intel has 3 Form 483s on file for Zhejiang Huahai Pharmaceutical Co., Ltd.; the most recent is dated Nov 20, 2024.
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 Nov 20, 2024, 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 211.192 (Production record review), 7 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 5 times; 21 CFR 211.100 (Written procedures; deviations), 3 times.