DR.REDDY'S Laboratories LIMITED
Form 483 issued August 20, 2019 · Duvvada, India
- Inspection
- Aug 12 – Aug 20, 2019
- Investigators
- Bijoy Panicker· Thomas J. Arista
- Observations
- 2
- Pages
- 15
- FEI number
- 3006549835
In short: On August 20, 2019, FDA issued a Form 483 with 2 observations to DR.REDDY'S Laboratories LIMITED in Duvvada, India (FEI 3006549835) after an inspection that ran Aug 12 – Aug 20, 2019. The investigators were Bijoy Panicker and Thomas J. Arista. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.22 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks authority to fully investigate…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
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 211.22
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 quality system and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected DR.REDDY'S Laboratories LIMITED?
Bijoy Panicker and Thomas J. Arista are named on this Form 483, for the inspection of Aug 12 – Aug 20, 2019. Each investigator has a profile showing what they cite most.
When was DR.REDDY'S Laboratories LIMITED inspected by FDA?
The inspection ran Aug 12 – Aug 20, 2019, and the Form 483 is dated August 20, 2019.
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.