Ercros SA
FDA inspection history in Aranjuez, Spain, 2012 to 2024
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2012: one warning letter; 2018: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012One warning letter, at Aranjuez, Spain.
- 2018One Form 483, at Aranjuez, Spain.
- 2024One Form 483, at Aranjuez, Spain.
- 2024The longest 483 on file: 9 observations over 8 pages at Aranjuez, Spain.
Cited most
Across all Ercros observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
The complete Ercros 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
Aranjuez, Spain
Two Form 483s and one warning letter · 2012 to 2024 · 16 observations
Latest: Form 483, Nov 22, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-22 | 483 Form 483 | Aranjuez, Spain | 9 | $99 |
| 2018-12-14 | 483 Form 483 | Aranjuez, Spain | 7 | $99 |
| 2012-06-20 | Warning letter Warning letter | Aranjuez, Spain | — | $99 |
Investigators on these documents
Damaris Y. Hernandez (1)Neeeee Damaris Hernandez (1)Satins Oe Damaris Hernandez (1)
FEI number 3003562118 · most recent document Nov 22, 2024
About Ercros SA
How many FDA Form 483s has Ercros SA received?
FDA Intel has 2 Form 483s on file for Ercros SA; the most recent is dated Nov 22, 2024.
When was Ercros SA last inspected by FDA?
The most recent FDA inspection document on file for Ercros SA is a Form 483 dated Nov 22, 2024, for the site in Aranjuez, Spain.
What did FDA cite at Ercros SA?
The regulations cited most in the observations on file for Ercros SA are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.
Has Ercros SA received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Ercros SA; the most recent is dated Jun 20, 2012.