Granules India Limited

FDA inspection history in Sangareddy, India, 2025

1
Form 483

Every document, by year

  • Form 483

2025: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2025One Form 483, at Sangareddy, India.

Cited most

Across all Granules India Limited observations on file

The complete Granules India Limited file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2025-06-20483 Form 483$99

Investigators on these documents

Karen A. Briggs (1)Karishma G. Gopaul (1)

FEI number 3003723146 · most recent document Jun 20, 2025

About Granules India Limited

How many FDA Form 483s has Granules India Limited received?

FDA Intel has 1 Form 483 on file for Granules India Limited; the most recent is dated Jun 20, 2025.

When was Granules India Limited last inspected by FDA?

The most recent FDA inspection document on file for Granules India Limited is a Form 483 dated Jun 20, 2025, for the site in Sangareddy, India.

What did FDA cite at Granules India Limited?

The regulations cited most in the observations on file for Granules India Limited are 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.