FEI 3004555163
FDA inspection history in Jiutepec, Mexico, 2018 to 2022
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2018: one close-out letter; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One close-out letter, at Jiutepec, Mexico.
- 2022One Form 483, at Jiutepec, Mexico.
Cited most
Across all site observations on file
- 21 CFR 211.194(a)Laboratory records2
- 21 CFR 211.166(a)(1)Stability testing1
- 21 CFR 211.170(b)Reserve samples1
- 21 CFR 211.25(c)Personnel qualifications1
- 21 CFR 211.42(a)Design and construction features1
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
Jiutepec, Mexico
One Form 483 and one close-out letter · 2018 to 2022 · 10 observations
Latest: Form 483, May 27, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-05-27 | 483 Form 483 | Jiutepec, Mexico | 10 | $99 |
| 2018-04-18 | Close-out Close-out letter | Jiutepec, Mexico | — | $99 |
Investigators on these documents
FEI number 3004555163 · most recent document May 27, 2022
About FEI 3004555163
How many FDA Form 483s has FEI 3004555163 received?
FDA Intel has 1 Form 483 on file for FEI 3004555163; the most recent is dated May 27, 2022.
When was FEI 3004555163 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3004555163 is a Form 483 dated May 27, 2022, for the site in Jiutepec, Mexico.
What did FDA cite at FEI 3004555163?
The regulations cited most in the observations on file for FEI 3004555163 are 21 CFR 211.194(a) (Laboratory records), 2 times; 21 CFR 211.166(a)(1) (Stability testing), 1 time; 21 CFR 211.170(b) (Reserve samples), 1 time.