Rovi Pharma Industrial Services SA
Form 483 issued June 2, 2023 · Alcala de Henares, Spain
- Inspection
- May 29 – Jun 2, 2023
- Investigator
- Saied A. Asbagh
- Observations
- 3
- Pages
- 2
- FEI number
- 3002989591
In short: On June 2, 2023, FDA issued a Form 483 with 3 observations to Rovi Pharma Industrial Services SA in Alcala de Henares, Spain (FEI 3002989591) after an inspection that ran May 29 – Jun 2, 2023. The investigator was Saied A. Asbagh. Most observations concern facilities & equipment and laboratory controls.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
The separate or defined areas necessary to prevent contamination…
- 03
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
This inspection in context
Saied A. Asbagh
12 documents · 2016–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmRovi Pharma Industrial Services SA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rovi Pharma Industrial Services SA?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Rovi Pharma Industrial Services SA?
Saied A. Asbagh is named on this Form 483, for the inspection of May 29 – Jun 2, 2023. Each investigator has a profile showing what they cite most.
When was Rovi Pharma Industrial Services SA inspected by FDA?
The inspection ran May 29 – Jun 2, 2023, and the Form 483 is dated June 2, 2023.
How do I get the full Form 483 for Rovi Pharma Industrial Services SA?
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.