Dr. Reddy's Laboratories Ltd.
Form 483 issued June 7, 2024 · Pydibhimavaram, India
- Inspection
- May 30 – Jun 7, 2024
- Investigators
- Joseph A. Piechocki· Tamil Arasu
- Observations
- 4
- Pages
- 8
- FEI number
- 3002949085
In short: On June 7, 2024, FDA issued a Form 483 with 4 observations to Dr. Reddy's Laboratories Ltd. in Pydibhimavaram, Andhra Pradesh (FEI 3002949085) after an inspection that ran May 30 – Jun 7, 2024. The investigators were Joseph A. Piechocki and Tamil Arasu. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and production account for 3 of 4 observations.
Most cited: 21 CFR 211.165 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Analytical methods were not validated or verified under the actual conditions of use. These methods are…
- 02
There is a failure to ensure that manufacturing processes are maintained…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
There is a failure to ensure that materials are not released before the satisfactory completion of…
This inspection in context
Joseph A. Piechocki
19 documents · 2021–2026
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 Ltd. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dr. Reddy's Laboratories Ltd.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, production and quality system. 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 Ltd.?
Joseph A. Piechocki and Tamil Arasu are named on this Form 483, for the inspection of May 30 – Jun 7, 2024. Each investigator has a profile showing what they cite most.
When was Dr. Reddy's Laboratories Ltd. inspected by FDA?
The inspection ran May 30 – Jun 7, 2024, and the Form 483 is dated June 7, 2024.
How do I get the full Form 483 for Dr. Reddy's Laboratories Ltd.?
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.