DR REDDY'S Laboratories LIMITED
Form 483 issued July 7, 2022 · Srikakulam, India
- Inspection
- Jun 30 – Jul 7, 2022
- Investigator
- Taichun Qin
- Observations
- 2
- Pages
- 2
- FEI number
- 3012414462
In short: On July 7, 2022, FDA issued a Form 483 with 2 observations to DR REDDY'S Laboratories LIMITED in Srikakulam, Andhra Pradesh (FEI 3012414462) after an inspection that ran Jun 30 – Jul 7, 2022. The investigator was Taichun Qin. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmDR REDDY'S Laboratories LIMITED history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
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 production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected DR REDDY'S Laboratories LIMITED?
Taichun Qin is named on this Form 483, for the inspection of Jun 30 – Jul 7, 2022. Each investigator has a profile showing what they cite most.
When was DR REDDY'S Laboratories LIMITED inspected by FDA?
The inspection ran Jun 30 – Jul 7, 2022, and the Form 483 is dated July 7, 2022.
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.