Form 483 · FEI 3005029956
Form 483 issued June 12, 2024 · Indrad, India
- Inspection
- Jun 3 – Jun 12, 2024
- Investigators
- Pratik S. Upadhyay· Steven A. Brettler
- Observations
- 3
- Pages
- 7
- FEI number
- 3005029956
In short: On June 12, 2024, FDA issued a Form 483 with 3 observations to an FDA-inspected site in Indrad, Gujarat (FEI 3005029956) after an inspection that ran Jun 3 – Jun 12, 2024. The investigators were Pratik S. Upadhyay and Steven A. Brettler. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no testing program designed to assess the stability…
- 02
(Repeat Observation from September 2022) There is a failure to thoroughly review any unexplained discrepancy and…
- 03
(Repeat Observation from September 2022) Equipment and utensils are not cleaned and maintained at appropriate intervals…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmSite history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Pratik S. Upadhyay and Steven A. Brettler are named on this Form 483, for the inspection of Jun 3 – Jun 12, 2024. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jun 3 – Jun 12, 2024, and the Form 483 is dated June 12, 2024.
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.