Global Medical Production Co.. Ltd
FDA inspection history in Jiaxing, China, 2015 to 2021
- 2
- Warning letters
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2015: one warning letter and one Form 483; 2021: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One warning letter and one Form 483, at Jiaxing, China.
- 2021One warning letter, at Jiaxing, China.
Cited most
Across all Global Medical Production Co.. observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.30Design controls1
- 21 CFR 820.50Purchasing controls1
- 21 CFR 820.75Process validation1
The complete Global Medical Production Co.. file.
All 4 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
Jiaxing, China
Two warning letters, one Form 483 and one close-out letter · 2015 to 2021 · 5 observations
Latest: Warning letter, Nov 16, 2021 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-11-16 | Warning letter Warning letter | Jiaxing, China | — | $99 |
| 2015-08-28 | Warning letter Warning letter | Jiaxing, China | — | $99 |
| 2015-04-30 | 483 Form 483 | Jiaxing, China | 5 | $99 |
| Undated | Close-out Close-out letter | Jiaxing, China | — | $99 |
Investigators on these documents
FEI number 3006897899 · most recent document Nov 16, 2021
About Global Medical Production Co.. Ltd
How many FDA Form 483s has Global Medical Production Co.. Ltd received?
FDA Intel has 1 Form 483 on file for Global Medical Production Co.. Ltd; the most recent is dated Apr 30, 2015.
When was Global Medical Production Co.. Ltd last inspected by FDA?
The most recent FDA inspection document on file for Global Medical Production Co.. Ltd is a Form 483 dated Apr 30, 2015, for the site in Jiaxing, China.
What did FDA cite at Global Medical Production Co.. Ltd?
The regulations cited most in the observations on file for Global Medical Production Co.. Ltd are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100 (Corrective and preventive action), 1 time; 21 CFR 820.30 (Design controls), 1 time.
Has Global Medical Production Co.. Ltd received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Global Medical Production Co.. Ltd; the most recent is dated Nov 16, 2021.