DR. REDDY'S Laboratories LIMITED
Form 483 issued February 17, 2017 · Nalgonda Dist., India
- Inspection
- Feb 13 – Feb 17, 2017
- Investigators
- Jose Lopez Rubet· Reba A. Gates
- Observations
- 1
- Pages
- 3
- FEI number
- 3005447965
In short: On February 17, 2017, FDA issued a Form 483 with 1 observation to DR. REDDY'S Laboratories LIMITED in Nalgonda Dist., India (FEI 3005447965) after an inspection that ran Feb 13 – Feb 17, 2017. The investigators were Jose Lopez Rubet and Reba A. Gates. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The specificity of test methods…
This inspection in context
Jose Lopez Rubet
5 documents · 2015–2019
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 211.165
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 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected DR. REDDY'S Laboratories LIMITED?
Jose Lopez Rubet and Reba A. Gates are named on this Form 483, for the inspection of Feb 13 – Feb 17, 2017. Each investigator has a profile showing what they cite most.
When was DR. REDDY'S Laboratories LIMITED inspected by FDA?
The inspection ran Feb 13 – Feb 17, 2017, and the Form 483 is dated February 17, 2017.
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.