Form 483 · FEI 3010166683
Form 483 issued February 21, 2025 · Balisinor, India
- Inspection
- Feb 17 – Feb 21, 2025
- Investigator
- Chad W. Rice
- Observations
- 1
- Pages
- 2
- FEI number
- 3010166683
In short: On February 21, 2025, FDA issued a Form 483 with 1 observation to an FDA-inspected site in Balisinor, Dist-Mahisagar (FEI 3010166683) after an inspection that ran Feb 17 – Feb 21, 2025. The investigator was Chad W. Rice. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Chad W. Rice
8 documents · 2023–2026
Cites 211.113(a) (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Chad W. Rice is named on this Form 483, for the inspection of Feb 17 – Feb 21, 2025. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Feb 17 – Feb 21, 2025, and the Form 483 is dated February 21, 2025.
How do I get the full Form 483 for an FDA-inspected site?
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.