FEI 3002808161
FDA inspection history in Toluca, Mexico, 2020 to 2022
- 2
- Close-outs
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2020: one close-out letter; 2022: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–22Two close-out letters and one Form 483, at Toluca, Mexico.
Cited most
Across all site observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.186Master production and control records1
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete site file.
All 3 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
Toluca, Mexico
One Form 483 · 2022 · 6 observations
Latest: Form 483, Apr 15, 2022 →
Also: two documents not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-07-07 | Close-out Close-out letter | — | — | $99 |
| 2022-04-15 | 483 Form 483 | Toluca, Mexico | 6 | $99 |
| 2020-07-14 | Close-out Close-out letter | — | — | $99 |
Investigators on these documents
FEI number 3002808161 · most recent document Jul 7, 2022
About FEI 3002808161
How many FDA Form 483s has FEI 3002808161 received?
FDA Intel has 1 Form 483 on file for FEI 3002808161; the most recent is dated Apr 15, 2022.
When was FEI 3002808161 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3002808161 is a Form 483 dated Apr 15, 2022, for the site in Toluca, Mexico.
What did FDA cite at FEI 3002808161?
The regulations cited most in the observations on file for FEI 3002808161 are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.186 (Master production and control records), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time.