Laboratorios Farmaceuticos Rovi S. A
Form 483 issued June 27, 2022 · Madrid, Spain
- Inspection
- Jun 27, 2022
- Investigator
- Arsen Karapetyan
- Observations
- 4
- Pages
- 5
- FEI number
- 3010705046
In short: On June 27, 2022, FDA issued a Form 483 with 4 observations to Laboratorios Farmaceuticos Rovi S. A in Madrid, Madrid (FEI 3010705046) after an inspection that ran Jun 27, 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 of investigations into unexplained discrepancies and the failure of a batch or any of…
- 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 firmLaboratorios Farmaceuticos Rovi S. A history
All 2 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 Laboratorios Farmaceuticos Rovi 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 Laboratorios Farmaceuticos Rovi S. A?
Arsen Karapetyan is named on this Form 483, for the inspection of Jun 27, 2022. Each investigator has a profile showing what they cite most.
When was Laboratorios Farmaceuticos Rovi S. A inspected by FDA?
The inspection ran Jun 27, 2022, and the Form 483 is dated June 27, 2022.
How do I get the full Form 483 for Laboratorios Farmaceuticos Rovi 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.