Dr. Reddy's Laboratories Ltd.
Form 483 issued January 28, 2020 · Srikakulam District, India
- Inspection
- Jan 20 – Jan 28, 2020
- Investigators
- Aditi S. Thakur· Dipesh K. Shah
- Observations
- 4
- Pages
- 8
- FEI number
- 3002949085
In short: On January 28, 2020, FDA issued a Form 483 with 4 observations to Dr. Reddy's Laboratories Ltd. in Srikakulam District, India (FEI 3002949085) after an inspection that ran Jan 20 – Jan 28, 2020. The investigators were Aditi S. Thakur and Dipesh K. Shah. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Process Validation is not performed adequately for manufactured products at…
- 02
Investigations are inadequate in that they do not evaluate…
- 03
Your firm 's cleaning processes for equipment have not been…
- 04
Trend Analysis of manufactured…
This inspection in context
Aditi S. Thakur
4 documents · 2018–2024
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 211.100
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 quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Dr. Reddy's Laboratories Ltd.?
Aditi S. Thakur and Dipesh K. Shah are named on this Form 483, for the inspection of Jan 20 – Jan 28, 2020. Each investigator has a profile showing what they cite most.
When was Dr. Reddy's Laboratories Ltd. inspected by FDA?
The inspection ran Jan 20 – Jan 28, 2020, and the Form 483 is dated January 28, 2020.
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.