J.B. Chemicals & Pharmaceuticals Ltd.
Form 483 issued February 7, 2020 · Bharuch, India
- Inspection
- Feb 3 – Feb 7, 2020
- Investigator
- Nicole E. Knowlton
- Observations
- 1
- Pages
- 3
- FEI number
- 3003053502
In short: On February 7, 2020, FDA issued a Form 483 with 1 observation to J.B. Chemicals & Pharmaceuticals Ltd. in Bharuch, Gujarat (FEI 3003053502) after an inspection that ran Feb 3 – Feb 7, 2020. The investigator was Nicole E. Knowlton. 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(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
The firmJ.B. Chemicals & Pharmaceuticals Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at J.B. Chemicals & Pharmaceuticals Ltd.?
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 J.B. Chemicals & Pharmaceuticals Ltd.?
Nicole E. Knowlton is named on this Form 483, for the inspection of Feb 3 – Feb 7, 2020. Each investigator has a profile showing what they cite most.
When was J.B. Chemicals & Pharmaceuticals Ltd. inspected by FDA?
The inspection ran Feb 3 – Feb 7, 2020, and the Form 483 is dated February 7, 2020.
How do I get the full Form 483 for J.B. Chemicals & Pharmaceuticals Ltd.?
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.