Rovi Pharma Industrial Services S.A.
Form 483 issued June 20, 2022 · San Sebastián de los Reyes, Spain
- Inspection
- Jun 6 – Jun 20, 2022
- Investigator
- Arsen Karapetyan
- Observations
- 4
- Pages
- 6
- FEI number
- 3016688535
In short: On June 20, 2022, 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 Jun 6 – Jun 20, 2022. The investigator was Arsen Karapetyan. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records are not always made of investigations into the failure of a batch or any…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
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 quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Rovi Pharma Industrial Services S.A.?
Arsen Karapetyan is named on this Form 483, for the inspection of Jun 6 – Jun 20, 2022. Each investigator has a profile showing what they cite most.
When was Rovi Pharma Industrial Services S.A. inspected by FDA?
The inspection ran Jun 6 – Jun 20, 2022, and the Form 483 is dated June 20, 2022.
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.