Granul es India Limited
Form 483 issued January 13, 2023 · Medchal-Malkajgiri District, India
- Inspection
- Jan 9 – Jan 13, 2023
- Observations
- 3
- Pages
- 7
- FEI number
- 3004097901
In short: On January 13, 2023, FDA issued a Form 483 with 3 observations to Granul es India Limited in Medchal-Malkajgiri District, Telangana (FEI 3004097901) after an inspection that ran Jan 9 – Jan 13, 2023. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (2×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Deviations from written production and process control…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Questions about this 483
What did FDA find at Granul es India Limited?
FDA listed 3 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was Granul es India Limited inspected by FDA?
The inspection ran Jan 9 – Jan 13, 2023, and the Form 483 is dated January 13, 2023.
How do I get the full Form 483 for Granul es India Limited?
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