Granules India Limited
Form 483 issued June 20, 2025 · Sangareddy, India
- Inspection
- Jun 16 – Jun 20, 2025
- Investigators
- Karen A. Briggs· Karishma G. Gopaul
- Observations
- 1
- Pages
- 1
- FEI number
- 3003723146
In short: On June 20, 2025, FDA issued a Form 483 with 1 observation to Granules India Limited in Sangareddy, Telangana (FEI 3003723146) after an inspection that ran Jun 16 – Jun 20, 2025. The investigators were Karen A. Briggs and Karishma G. Gopaul. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 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
Failure to document and investigate a…
This inspection in context
Karen A. Briggs
19 documents · 2021–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Virginia.
The firmGranules India Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Granules India Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Granules India Limited?
Karen A. Briggs and Karishma G. Gopaul are named on this Form 483, for the inspection of Jun 16 – Jun 20, 2025. Each investigator has a profile showing what they cite most.
When was Granules India Limited inspected by FDA?
The inspection ran Jun 16 – Jun 20, 2025, and the Form 483 is dated June 20, 2025.
How do I get the full Form 483 for Granules India Limited?
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