FEI 3000538793
FDA inspection history in Ramos Arizpe, Mexico, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Ramos Arizpe, Mexico.
Cited most
Across all site observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.142Warehousing procedures1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete site file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Ramos Arizpe, Mexico
One Form 483 · 2022 · 6 observations
Latest: Form 483, Sep 23, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-23 | 483 Form 483 | Ramos Arizpe, Mexico | 6 | $99 |
Investigators on these documents
Eal I. Ee (1)Lori B. Wikstrom (1)Suzanne N. Vallez (1)Taichun Qin (1)
FEI number 3000538793 · most recent document Sep 23, 2022
About FEI 3000538793
How many FDA Form 483s has FEI 3000538793 received?
FDA Intel has 1 Form 483 on file for FEI 3000538793; the most recent is dated Sep 23, 2022.
When was FEI 3000538793 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3000538793 is a Form 483 dated Sep 23, 2022, for the site in Ramos Arizpe, Mexico.
What did FDA cite at FEI 3000538793?
The regulations cited most in the observations on file for FEI 3000538793 are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.142 (Warehousing procedures), 1 time; 21 CFR 211.188 (Batch production and control records), 1 time.