Laboratorios Farmaceuticos Rovi S. A
Form 483 issued May 19, 2023 · Madrid, Spain
- Inspection
- May 11 – May 19, 2023
- Investigator
- Sandra A. Boyd
- Observations
- 6
- Pages
- 7
- FEI number
- 3010705046
In short: On May 19, 2023, FDA issued a Form 483 with 6 observations to Laboratorios Farmaceuticos Rovi S. A in Madrid, Madrid (FEI 3010705046) after an inspection that ran May 11 – May 19, 2023. The investigator was Sandra A. Boyd. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 5 of 6 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Sandra A. Boyd
16 documents · 2019–2026
Cites 211.113 (control of microbiological contamination) 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 211.113
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 6 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Laboratorios Farmaceuticos Rovi S. A?
Sandra A. Boyd is named on this Form 483, for the inspection of May 11 – May 19, 2023. Each investigator has a profile showing what they cite most.
When was Laboratorios Farmaceuticos Rovi S. A inspected by FDA?
The inspection ran May 11 – May 19, 2023, and the Form 483 is dated May 19, 2023.
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.