Rovi Pharma Industrial Services S.A.
Form 483 issued September 22, 2023 · San Sebastian De Los Reyes, Spain
- Inspection
- Sep 18 – Sep 22, 2023
- Investigators
- Dorothy P. Kramer· Jennifer Lalama
- Observations
- 2
- Pages
- 2
- FEI number
- 3016688535
In short: On September 22, 2023, FDA issued a Form 483 with 2 observations to Rovi Pharma Industrial Services S.A. in San Sebastian De Los Reyes, Spain (FEI 3016688535) after an inspection that ran Sep 18 – Sep 22, 2023. The investigators were Dorothy P. Kramer and Jennifer Lalama. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment…
This inspection in context
Dorothy P. Kramer
9 documents · 2022–2025
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
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 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Rovi Pharma Industrial Services S.A.?
Dorothy P. Kramer and Jennifer Lalama are named on this Form 483, for the inspection of Sep 18 – Sep 22, 2023. Each investigator has a profile showing what they cite most.
When was Rovi Pharma Industrial Services S.A. inspected by FDA?
The inspection ran Sep 18 – Sep 22, 2023, and the Form 483 is dated September 22, 2023.
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.