FEI 3004058356
FDA inspection history in Pune, India, 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 Pune, India.
Cited most
Across all site observations on file
- 21 CFR 211.22Responsibilities of quality control unit1
The complete site 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
Pune, India
One Form 483 · 2016 · 1 observation
Latest: Form 483, Aug 19, 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 |
| 2016-08-19 | 483 Form 483 | Pune, India | 1 | $99 |
Investigators on these documents
FEI number 3004058356 · most recent document Mar 2, 2017
About FEI 3004058356
How many FDA Form 483s has FEI 3004058356 received?
FDA Intel has 1 Form 483 on file for FEI 3004058356; the most recent is dated Aug 19, 2016.
When was FEI 3004058356 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3004058356 is a Form 483 dated Aug 19, 2016, for the site in Pune, India.
What did FDA cite at FEI 3004058356?
The regulations cited most in the observations on file for FEI 3004058356 are 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.
Has FEI 3004058356 received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for FEI 3004058356; the most recent is dated Mar 2, 2017.