DR. REDDY'S LABORATORIES LTD
Form 483 issued September 12, 2025 · Telangana, India
- Inspection
- Sep 4 – Sep 12, 2025
- Investigators
- Baikuntha Aryal· Jiangsong Jiang· Madushini Dharmasena
- Observations
- 5
- Pages
- 7
- FEI number
- 3014250111
In short: On September 12, 2025, FDA issued a Form 483 with 5 observations to DR. REDDY'S LABORATORIES LTD in Telangana, India (FEI 3014250111) after an inspection that ran Sep 4 – Sep 12, 2025. The investigators were Baikuntha Aryal, Jiangsong Jiang and Madushini Dharmasena. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Production and quality system account for 3 of 4 observations.
Most cited: 21 CFR 211.68 (2×) · 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
The Quality Unit has not established adequate procedural controls and oversight to ensure the accuracy of…
- 02
The firm failed to establish adequate document control procedures and oversight mechanisms to ensure appropriate…
- 04
The risk assessment (QUA-BTO-2275 - Risk assessment for viral cross-contamination control in drug product manufacturing at…
- 05
Written documents are inadequate to ensure proper documentation and analysis…
This inspection in context
Baikuntha Aryal
1 document · 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 LTD history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DR. REDDY'S LABORATORIES LTD?
FDA listed 5 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected DR. REDDY'S LABORATORIES LTD?
Baikuntha Aryal, Jiangsong Jiang and Madushini Dharmasena are named on this Form 483, for the inspection of Sep 4 – Sep 12, 2025. Each investigator has a profile showing what they cite most.
When was DR. REDDY'S LABORATORIES LTD inspected by FDA?
The inspection ran Sep 4 – Sep 12, 2025, and the Form 483 is dated September 12, 2025.
How do I get the full Form 483 for DR. REDDY'S LABORATORIES LTD?
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.