Dr. Reddy's Laboratories Ltd.
Form 483 issued October 12, 2023 · Hyderabad, India
- Inspection
- Oct 4 – Oct 12, 2023
- Investigators
- Madushini Dharmasena· Zhong Zhao
- Observations
- 9
- Pages
- 5
In short: On October 12, 2023, FDA issued a Form 483 with 9 observations to Dr. Reddy's Laboratories Ltd. in Hyderabad, India after an inspection that ran Oct 4 – Oct 12, 2023. The investigators were Madushini Dharmasena and Zhong Zhao. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 7 of 9 observations.
Most cited: 21 CFR 211.113 (4×) · 211.192 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
The drug substance manufacturing areas are not…
- 03
The investigations and corrective actions due to visual inspection limit excursion are inadequate to address defective…
- 04
The post PPQ drug substance manufacturing…
This inspection in context
Madushini Dharmasena
13 documents · 2019–2025
Cites 211.113 (control of microbiological contamination) 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 211.113
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 9 observations on this Form 483, mostly about production, facilities & equipment 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 Ltd.?
Madushini Dharmasena and Zhong Zhao are named on this Form 483, for the inspection of Oct 4 – Oct 12, 2023. Each investigator has a profile showing what they cite most.
When was Dr. Reddy's Laboratories Ltd. inspected by FDA?
The inspection ran Oct 4 – Oct 12, 2023, and the Form 483 is dated October 12, 2023.
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.