1 umisGloh.il Pharmaceuticals Co.. Ltd
FDA inspection history in Wuhan. Hubei, China, 2016 to 2017
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2016: one Form 483; 2017: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17One Form 483 and one warning letter, at Wuhan. Hubei, China.
Cited most
Across all 1 umisGloh.il Pharmaceuticals Co.. observations on file
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.56Sanitation1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
- 21 CFR 211.89Rejected components, drug product containers, and closures1
The complete 1 umisGloh.il Pharmaceuticals 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
Wuhan. Hubei, China
One Form 483 · 2016 · 9 observations
Latest: Form 483, Sep 28, 2016 →
Also: one document not tied to a site.
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-03-02 | Warning letter Warning letter | — | — | $99 |
| 2016-09-28 | 483 Form 483 | Wuhan. Hubei, China | 9 | $99 |
Investigators on these documents
FEI number 3010280514 · most recent document Mar 2, 2017
About 1 umisGloh.il Pharmaceuticals Co.. Ltd
How many FDA Form 483s has 1 umisGloh.il Pharmaceuticals Co.. Ltd received?
FDA Intel has 1 Form 483 on file for 1 umisGloh.il Pharmaceuticals Co.. Ltd; the most recent is dated Sep 28, 2016.
When was 1 umisGloh.il Pharmaceuticals Co.. Ltd last inspected by FDA?
The most recent FDA inspection document on file for 1 umisGloh.il Pharmaceuticals Co.. Ltd is a Form 483 dated Sep 28, 2016, for the site in Wuhan. Hubei, China.
What did FDA cite at 1 umisGloh.il Pharmaceuticals Co.. Ltd?
The regulations cited most in the observations on file for 1 umisGloh.il Pharmaceuticals Co.. Ltd are 21 CFR 211.188 (Batch production and control records), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time; 21 CFR 211.56 (Sanitation), 1 time.
Has 1 umisGloh.il Pharmaceuticals Co.. Ltd received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for 1 umisGloh.il Pharmaceuticals Co.. Ltd; the most recent is dated Mar 2, 2017.