Naari Pharma Private Limited
Form 483 issued January 27, 2023 · Rudrapur, India
- Inspection
- Jan 23 – Jan 27, 2023
- Investigator
- Jogy George
- Observations
- 2
- Pages
- 4
- FEI number
- 3014247908
In short: On January 27, 2023, FDA issued a Form 483 with 2 observations to Naari Pharma Private Limited in Rudrapur, Uttarakhand (FEI 3014247908) after an inspection that ran Jan 23 – Jan 27, 2023. The investigator was Jogy George. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations from written production and process control procedures…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Jogy George
15 documents · 2016–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in India.
The firmNaari Pharma Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Naari Pharma Private Limited?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Naari Pharma Private Limited?
Jogy George is named on this Form 483, for the inspection of Jan 23 – Jan 27, 2023. Each investigator has a profile showing what they cite most.
When was Naari Pharma Private Limited inspected by FDA?
The inspection ran Jan 23 – Jan 27, 2023, and the Form 483 is dated January 27, 2023.
How do I get the full Form 483 for Naari 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.