Granul es India Limited
Form 483 issued September 6, 2024 · Medchal-Malkhajgiri District, India
- Inspection
- Aug 26 – Sep 6, 2024
- Investigators
- Joseph A. Piechocki· Pratik S. Upadhyay
- Observations
- 5
- Pages
- 28
- FEI number
- 3004097901
In short: On September 6, 2024, FDA issued a Form 483 with 5 observations to Granul es India Limited in Medchal-Malkhajgiri District, India (FEI 3004097901) after an inspection that ran Aug 26 – Sep 6, 2024. The investigators were Joseph A. Piechocki and Pratik S. Upadhyay. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Quality system and production account for 4 of 5 observations.
Most cited: 21 CFR 211.110 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
A. The process o <~material from thcl '~commonly performed during routine manufacturing, including! (b)(4~sed in <b><jontaining…
This inspection in context
Joseph A. Piechocki
19 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmGranul es India Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Granul es India Limited?
FDA listed 5 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Granul es India Limited?
Joseph A. Piechocki and Pratik S. Upadhyay are named on this Form 483, for the inspection of Aug 26 – Sep 6, 2024. Each investigator has a profile showing what they cite most.
When was Granul es India Limited inspected by FDA?
The inspection ran Aug 26 – Sep 6, 2024, and the Form 483 is dated September 6, 2024.
How do I get the full Form 483 for Granul es India 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.