FEI 3009713694
FDA inspection history in Toledo, Spain, 2019 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Toledo, Spain.
- 2023One Form 483, at Toledo, Spain.
- 2023The longest 483 on file: 7 observations over 17 pages at Toledo, Spain.
Cited most
Across all site observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.160(b)General requirements1
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
Toledo, Spain
Two Form 483s · 2019 to 2023 · 11 observations
Latest: Form 483, Jun 23, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-06-23 | 483 Form 483 | Toledo, Spain | 7 | $99 |
| 2019-06-14 | 483 Form 483 | Toledo, Spain | 4 | $99 |
Investigators on these documents
Darren S. Brown (1)Junho Pak (1)Pratik S. Upadhyay (1)Xiaokuang Lai (1)
FEI number 3009713694 · most recent document Jun 23, 2023
About FEI 3009713694
How many FDA Form 483s has FEI 3009713694 received?
FDA Intel has 2 Form 483s on file for FEI 3009713694; the most recent is dated Jun 23, 2023.
When was FEI 3009713694 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3009713694 is a Form 483 dated Jun 23, 2023, for the site in Toledo, Spain.
What did FDA cite at FEI 3009713694?
The regulations cited most in the observations on file for FEI 3009713694 are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.165 (Testing and release for distribution), 2 times; 21 CFR 211.194 (Laboratory records), 2 times.