Laboratorios Farmaceuticos Rovi S. A
FDA inspection history in Madrid, Spain, 2022 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23Two Form 483s, at Madrid, Spain.
- 2023The longest 483 on file: 6 observations over 7 pages at Madrid, Spain.
Cited most
Across all Laboratorios Farmaceuticos Rovi S. A observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.22Responsibilities of quality control unit2
- 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 Laboratorios Farmaceuticos Rovi S. A 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
Madrid, Spain
Two Form 483s · 2022 to 2023 · 10 observations
Latest: Form 483, May 19, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-05-19 | 483 Form 483 | Madrid, Spain | 6 | $99 |
| 2022-06-27 | 483 Form 483 | Madrid, Spain | 4 | $99 |
Investigators on these documents
FEI number 3010705046 · most recent document May 19, 2023
About Laboratorios Farmaceuticos Rovi S. A
How many FDA Form 483s has Laboratorios Farmaceuticos Rovi S. A received?
FDA Intel has 2 Form 483s on file for Laboratorios Farmaceuticos Rovi S. A; the most recent is dated May 19, 2023.
When was Laboratorios Farmaceuticos Rovi S. A last inspected by FDA?
The most recent FDA inspection document on file for Laboratorios Farmaceuticos Rovi S. A is a Form 483 dated May 19, 2023, for the site in Madrid, Spain.
What did FDA cite at Laboratorios Farmaceuticos Rovi S. A?
The regulations cited most in the observations on file for Laboratorios Farmaceuticos Rovi S. A are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.