Dr. Reddy's Laboratories Limited (Unit II)
Form 483 issued July 12, 2019 · Bollaram, India
- Inspection
- Jul 8 – Jul 12, 2019
- Investigators
- Christopher Keating· Ralph H. Vocque
- Observations
- 1
- Pages
- 5
- FEI number
- 3005448030
In short: On July 12, 2019, FDA issued a Form 483 with 1 observation to Dr. Reddy's Laboratories Limited (Unit II) in Bollaram, India (FEI 3005448030) after an inspection that ran Jul 8 – Jul 12, 2019. The investigators were Christopher Keating and Ralph H. Vocque. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations into product complaints and out-of-specification QC analytical results, related to finished API product quality…
This inspection in context
Christopher Keating
13 documents · 2018–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmDr. Reddy's Laboratories Limited (Unit II) history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dr. Reddy's Laboratories Limited (Unit II)?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Dr. Reddy's Laboratories Limited (Unit II)?
Christopher Keating and Ralph H. Vocque are named on this Form 483, for the inspection of Jul 8 – Jul 12, 2019. Each investigator has a profile showing what they cite most.
When was Dr. Reddy's Laboratories Limited (Unit II) inspected by FDA?
The inspection ran Jul 8 – Jul 12, 2019, and the Form 483 is dated July 12, 2019.
How do I get the full Form 483 for Dr. Reddy's Laboratories Limited (Unit II)?
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