DR.REDDY'S Laboratories LIMITED
Form 483 issued June 21, 2019 · Visakhapatnam, India
- Inspection
- Jun 13 – Jun 21, 2019
- Investigators
- Farhana Khan· Monica C. Burgos Garcia
- Observations
- 2
- Pages
- 3
- FEI number
- 3006549835
In short: On June 21, 2019, FDA issued a Form 483 with 2 observations to DR.REDDY'S Laboratories LIMITED in Visakhapatnam, India (FEI 3006549835) after an inspection that ran Jun 13 – Jun 21, 2019. The investigators were Farhana Khan and Monica C. Burgos Garcia. Most observations concern laboratory controls and design controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and design controls account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 820.30 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Acceptance criteria were not established prior to the…
- 02
The device design was not correctly…
This inspection in context
Farhana Khan
7 documents · 2016–2021
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 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
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 laboratory controls and design controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected DR.REDDY'S Laboratories LIMITED?
Farhana Khan and Monica C. Burgos Garcia are named on this Form 483, for the inspection of Jun 13 – Jun 21, 2019. Each investigator has a profile showing what they cite most.
When was DR.REDDY'S Laboratories LIMITED inspected by FDA?
The inspection ran Jun 13 – Jun 21, 2019, and the Form 483 is dated June 21, 2019.
How do I get the full Form 483 for DR.REDDY'S Laboratories LIMITED?
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