DR REDDY'S Laboratories LIMITED
Form 483 issued July 18, 2025 · Srikakulam, India
- Inspection
- Jul 10 – Jul 18, 2025
- Investigators
- Jigar R. Patel· Patty P. Kaewussdangkul
- Observations
- 7
- Pages
- 7
- FEI number
- 3012414462
In short: On July 18, 2025, FDA issued a Form 483 with 7 observations to DR REDDY'S Laboratories LIMITED in Srikakulam, Andhra Pradesh (FEI 3012414462) after an inspection that ran Jul 10 – Jul 18, 2025. The investigators were Jigar R. Patel and Patty P. Kaewussdangkul. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 5 of 7 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of adequate…
This inspection in context
Jigar R. Patel
2 documents · 2024–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmDR REDDY'S Laboratories LIMITED history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DR REDDY'S Laboratories LIMITED?
FDA listed 7 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected DR REDDY'S Laboratories LIMITED?
Jigar R. Patel and Patty P. Kaewussdangkul are named on this Form 483, for the inspection of Jul 10 – Jul 18, 2025. Each investigator has a profile showing what they cite most.
When was DR REDDY'S Laboratories LIMITED inspected by FDA?
The inspection ran Jul 10 – Jul 18, 2025, and the Form 483 is dated July 18, 2025.
How do I get the full Form 483 for DR REDDY'S Laboratories 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.