DR. REDDY'S Laboratories LIMITED
Form 483 issued May 24, 2025 · Nalgonda, India
- Inspection
- May 19 – May 24, 2025
- Investigator
- Santos E. Camara
- Observations
- 2
- Pages
- 2
- FEI number
- 3005447965
In short: On May 24, 2025, FDA issued a Form 483 with 2 observations to DR. REDDY'S Laboratories LIMITED in Nalgonda, Telangana (FEI 3005447965) after an inspection that ran May 19 – May 24, 2025. The investigator was Santos E. Camara. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Production System Failure to ensure that equipment surfaces in contact with raw materials for APIs (Active…
- 02
Failure to document in batch production records all quality-related activities at the…
This inspection in context
Santos E. Camara
33 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmDR. REDDY'S Laboratories 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 211.67
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 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected DR. REDDY'S Laboratories LIMITED?
Santos E. Camara is named on this Form 483, for the inspection of May 19 – May 24, 2025. Each investigator has a profile showing what they cite most.
When was DR. REDDY'S Laboratories LIMITED inspected by FDA?
The inspection ran May 19 – May 24, 2025, and the Form 483 is dated May 24, 2025.
How do I get the full Form 483 for DR. REDDY'S Laboratories LIMITED?
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