Kumar Organic Products Limited
Form 483 issued April 21, 2023 · Vadodara, India
- Inspection
- Apr 17 – Apr 21, 2023
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 1
- Pages
- 2
- FEI number
- 3009167769
In short: On April 21, 2023, FDA issued a Form 483 with 1 observation to Kumar Organic Products Limited in Vadodara, Gujarat (FEI 3009167769) after an inspection that ran Apr 17 – Apr 21, 2023. The investigator was Patty P. Kaewussdangkul. 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 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmKumar Organic Products Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kumar Organic Products 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 Kumar Organic Products Limited?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Apr 17 – Apr 21, 2023. Each investigator has a profile showing what they cite most.
When was Kumar Organic Products Limited inspected by FDA?
The inspection ran Apr 17 – Apr 21, 2023, and the Form 483 is dated April 21, 2023.
How do I get the full Form 483 for Kumar Organic Products 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.