Shouguang Fukang Pharmaceutical Co., Ltd.
FDA inspection history across 2 sites, 2018 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Shouguang, China.
- 2025One Form 483, at Shouguang City, China.
- 2025The longest 483 on file: 9 observations over 7 pages at Shouguang City, China.
Cited most
Across all Shouguang Fukang Pharmaceutical Co. observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.113Control of microbiological contamination1
The complete Shouguang Fukang Pharmaceutical Co. file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Shouguang City, China
One Form 483 · 2025 · 9 observations
Latest: Form 483, Feb 21, 2025 →Shouguang, China
One Form 483 · 2018 · 5 observations
Latest: Form 483, May 25, 2018 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-02-21 | 483 Form 483 | Shouguang City, China | 9 | $99 |
| 2018-05-25 | 483 Form 483 | Shouguang, China | 5 | $99 |
Investigators on these documents
FEI number 3003941038 · most recent document Feb 21, 2025
About Shouguang Fukang Pharmaceutical Co., Ltd.
How many FDA Form 483s has Shouguang Fukang Pharmaceutical Co., Ltd. received?
FDA Intel has 2 Form 483s on file for Shouguang Fukang Pharmaceutical Co., Ltd.; the most recent is dated Feb 21, 2025.
When was Shouguang Fukang Pharmaceutical Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Shouguang Fukang Pharmaceutical Co., Ltd. is a Form 483 dated Feb 21, 2025, for the site in Shouguang City, China.
What did FDA cite at Shouguang Fukang Pharmaceutical Co., Ltd.?
The regulations cited most in the observations on file for Shouguang Fukang Pharmaceutical Co., Ltd. are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.