Zhuhai United Laboratories Co., Ltd
FDA inspection history in Zhuhai, China, 2015 to 2023
- 4
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2015: one Form 483; 2017: one Form 483; 2018: one close-out letter; 2019: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–19Three Form 483s and one close-out letter, at Zhuhai, China.
- 2015The longest 483 on file: 11 observations over 9 pages at Zhuhai, China.
- 2023One Form 483, at Zhuhai, China.
Cited most
Across all Zhuhai United Laboratories Co. observations on file
- 21 CFR 211.113Control of microbiological contamination8
- 21 CFR 211.192Production record review7
- 21 CFR 211.160General requirements6
- 21 CFR 211.68Automatic, mechanical, and electronic equipment6
- 21 CFR 211.165Testing and release for distribution4
The complete Zhuhai United Laboratories Co. file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Zhuhai, China
Four Form 483s and one close-out letter · 2015 to 2023 · 19 observations
Latest: Form 483, Aug 3, 2023 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-03 | 483 Form 483 | Zhuhai, China | — | $99 |
| 2019-07-16 | 483 Form 483 | Zhuhai, China | 8 | $99 |
| 2018-06-27 | Close-out Close-out letter | Zhuhai, China | — | $99 |
| 2017-09-15 | 483 Form 483 | Zhuhai, China | — | $99 |
| 2015-03-31 | 483 Form 483 | Zhuhai, China | 11 | $99 |
Investigators on these documents
Ied Muiz (1)Justin A. Boyd (1)Ones Mi Lh (1)Raquel Gonzalez (1)Rumany C. Penn (1)Vincent Thomas (1)
FEI number 3006531950 · most recent document Aug 3, 2023
About Zhuhai United Laboratories Co., Ltd
How many FDA Form 483s has Zhuhai United Laboratories Co., Ltd received?
FDA Intel has 4 Form 483s on file for Zhuhai United Laboratories Co., Ltd; the most recent is dated Aug 3, 2023.
When was Zhuhai United Laboratories Co., Ltd last inspected by FDA?
The most recent FDA inspection document on file for Zhuhai United Laboratories Co., Ltd is a Form 483 dated Aug 3, 2023, for the site in Zhuhai, China.
What did FDA cite at Zhuhai United Laboratories Co., Ltd?
The regulations cited most in the observations on file for Zhuhai United Laboratories Co., Ltd are 21 CFR 211.113 (Control of microbiological contamination), 8 times; 21 CFR 211.192 (Production record review), 7 times; 21 CFR 211.160 (General requirements), 6 times.