Bajaj Nutraceuticals
Form 483 issued November 29, 2024 · Roorkee, India
- Inspection
- Nov 25 – Nov 29, 2024
- Investigator
- Truong X. Nguyen
- Observations
- 1
- Pages
- 1
- FEI number
- 3015077059
In short: On November 29, 2024, FDA issued a Form 483 with 1 observation to Bajaj Nutraceuticals in Roorkee, Uttarakhand (FEI 3015077059) after an inspection that ran Nov 25 – Nov 29, 2024. The investigator was Truong X. Nguyen. 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
Truong X. Nguyen
20 documents · 2011–2026
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmBajaj Nutraceuticals 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 Bajaj Nutraceuticals?
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 Bajaj Nutraceuticals?
Truong X. Nguyen is named on this Form 483, for the inspection of Nov 25 – Nov 29, 2024. Each investigator has a profile showing what they cite most.
When was Bajaj Nutraceuticals inspected by FDA?
The inspection ran Nov 25 – Nov 29, 2024, and the Form 483 is dated November 29, 2024.
How do I get the full Form 483 for Bajaj Nutraceuticals?
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.