Ritsa Pharma Private Limited
Form 483 issued September 5, 2025
- Inspection
- Sep 1 – Sep 5, 2025
- Investigator
- Pearl C. Ozuruigbo
- Observations
- 1
- Pages
- 2
- FEI number
- 3025926685
In short: On September 5, 2025, FDA issued a Form 483 with 1 observation to Ritsa Pharma Private Limited (FEI 3025926685) after an inspection that ran Sep 1 – Sep 5, 2025. The investigator was Pearl C. Ozuruigbo. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84(d)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
This inspection in context
Pearl C. Ozuruigbo
6 documents · 2024–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmRitsa Pharma Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ritsa Pharma Private Limited?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Ritsa Pharma Private Limited?
Pearl C. Ozuruigbo is named on this Form 483, for the inspection of Sep 1 – Sep 5, 2025. Each investigator has a profile showing what they cite most.
When was Ritsa Pharma Private Limited inspected by FDA?
The inspection ran Sep 1 – Sep 5, 2025, and the Form 483 is dated September 5, 2025.
How do I get the full Form 483 for Ritsa Pharma Private Limited?
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.