Bioiberica SAU
FDA inspection history in Palafolls, Spain, 2022 to 2024
- 2
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2022: one warning letter and one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–24Two Form 483s and one warning letter, at Palafolls, Spain.
- 2022The longest 483 on file: 5 observations over 5 pages at Palafolls, Spain.
Cited most
Across all Bioiberica SAU observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160General requirements1
- 21 CFR 211.166Stability testing1
The complete Bioiberica SAU file.
All 4 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
Palafolls, Spain
Two Form 483s, one warning letter and one close-out letter · 2022 to 2024 · 7 observations
Latest: Form 483, Sep 20, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-20 | 483 Form 483 | Palafolls, Spain | 2 | $99 |
| 2022-06-30 | Warning letter Warning letter | Palafolls, Spain | — | $99 |
| 2022-02-04 | 483 Form 483 | Palafolls, Spain | 5 | $99 |
| Undated | Close-out Close-out letter | Palafolls, Spain | — | $99 |
Investigators on these documents
FEI number 1000418405 · most recent document Sep 20, 2024
About Bioiberica SAU
How many FDA Form 483s has Bioiberica SAU received?
FDA Intel has 2 Form 483s on file for Bioiberica SAU; the most recent is dated Sep 20, 2024.
When was Bioiberica SAU last inspected by FDA?
The most recent FDA inspection document on file for Bioiberica SAU is a Form 483 dated Sep 20, 2024, for the site in Palafolls, Spain.
What did FDA cite at Bioiberica SAU?
The regulations cited most in the observations on file for Bioiberica SAU are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.
Has Bioiberica SAU received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Bioiberica SAU; the most recent is dated Jun 30, 2022.