Dr. Reddy's Laboratories Ltd.
Form 483 issued May 12, 2023 · Srikakulam, India
- Inspection
- May 8 – May 12, 2023
- Investigators
- Javier Vega· Junho Pak
- Observations
- 4
- Pages
- 4
- FEI number
- 3011171511
In short: On May 12, 2023, FDA issued a Form 483 with 4 observations to Dr. Reddy's Laboratories Ltd. in Srikakulam, Andhra Pradesh (FEI 3011171511) after an inspection that ran May 8 – May 12, 2023. The investigators were Javier Vega and Junho Pak. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Manufacturing equipment required for commercial manufacturing have not been installed and qualified for the PO products…
- 02
Manufacturing equipment are not cleaned and maintained to prevent contamination that would alter the safety, identity…
- 03
Manufacturing equipment is not maintained and operated to assure proper performance…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specification, designed to assure…
This inspection in context
Javier Vega
1 document · 2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in India.
The firmDr. Reddy's Laboratories Ltd. history
The site's inspection history, in date order.
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 Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and laboratory controls. 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 Ltd.?
Javier Vega and Junho Pak are named on this Form 483, for the inspection of May 8 – May 12, 2023. Each investigator has a profile showing what they cite most.
When was Dr. Reddy's Laboratories Ltd. inspected by FDA?
The inspection ran May 8 – May 12, 2023, and the Form 483 is dated May 12, 2023.
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.