Rovi Pharma Industrial Services S.A.
FDA inspection history across 2 sites, 2022 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2023: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–25Three Form 483s, at San Sebastián de los Reyes, Spain and San Sebastian De Los Reyes, Spain.
- 2022The longest 483 on file: 4 observations over 6 pages at San Sebastián de los Reyes, Spain.
Cited most
Across all Rovi Pharma Industrial Services observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.188(b)(2)Batch production and control records1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.63Equipment design, size, and location1
The complete Rovi Pharma Industrial Services 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
San Sebastián de los Reyes, Spain
Two Form 483s · 2022 to 2025 · 8 observations
Latest: Form 483, Jan 31, 2025 →San Sebastian De Los Reyes, Spain
One Form 483 · 2023 · 2 observations
Latest: Form 483, Sep 22, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-31 | 483 Form 483 | San Sebastián de los Reyes, Spain | 4 | $99 |
| 2023-09-22 | 483 Form 483 | San Sebastian De Los Reyes, Spain | 2 | $99 |
| 2022-06-20 | 483 Form 483 | San Sebastián de los Reyes, Spain | 4 | $99 |
Investigators on these documents
Arsen Karapetyan (1)Burnell M. Henry (1)Dorothy P. Kramer (1)Jennifer Lalama (1)
FEI number 3016688535 · most recent document Jan 31, 2025
About Rovi Pharma Industrial Services S.A.
How many FDA Form 483s has Rovi Pharma Industrial Services S.A. received?
FDA Intel has 3 Form 483s on file for Rovi Pharma Industrial Services S.A.; the most recent is dated Jan 31, 2025.
When was Rovi Pharma Industrial Services S.A. last inspected by FDA?
The most recent FDA inspection document on file for Rovi Pharma Industrial Services S.A. is a Form 483 dated Jan 31, 2025, for the site in San Sebastián de los Reyes, Spain.
What did FDA cite at Rovi Pharma Industrial Services S.A.?
The regulations cited most in the observations on file for Rovi Pharma Industrial Services S.A. are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.188(b)(2) (Batch production and control records), 1 time.