Rovi Pharma Industrial Services S.A.
Form 483 issued January 31, 2025 · San Sebastián de los Reyes, Spain
- Inspection
- Jan 23 – Jan 31, 2025
- Investigator
- Burnell M. Henry
- Observations
- 4
- Pages
- 5
- FEI number
- 3016688535
In short: On January 31, 2025, FDA issued a Form 483 with 4 observations to Rovi Pharma Industrial Services S.A. in San Sebastián de los Reyes, Spain (FEI 3016688535) after an inspection that ran Jan 23 – Jan 31, 2025. The investigator was Burnell M. Henry. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
(b) (4) from records or data are…
- 04
The batch production and control records are deficient in that they do not include the identity…
This inspection in context
Burnell M. Henry
22 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in North Carolina.
The firmRovi Pharma Industrial Services S.A. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rovi Pharma Industrial Services S.A.?
FDA listed 4 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Rovi Pharma Industrial Services S.A.?
Burnell M. Henry is named on this Form 483, for the inspection of Jan 23 – Jan 31, 2025. Each investigator has a profile showing what they cite most.
When was Rovi Pharma Industrial Services S.A. inspected by FDA?
The inspection ran Jan 23 – Jan 31, 2025, and the Form 483 is dated January 31, 2025.
How do I get the full Form 483 for Rovi Pharma Industrial Services S.A.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.