Dr. Reddy's Laboratories (EU) Ltd. Steanard Lane
Form 483 issued September 5, 2025 · Mirfield, United Kingdom
- Inspection
- Sep 1 – Sep 5, 2025
- Investigators
- Arsen Karapetyan· Yoriann M. Cabrera Bartolomei
- Observations
- 2
- Pages
- 7
In short: On September 5, 2025, FDA issued a Form 483 with 2 observations to Dr. Reddy's Laboratories (EU) Ltd. Steanard Lane in Mirfield, United Kingdom after an inspection that ran Sep 1 – Sep 5, 2025. The investigators were Arsen Karapetyan and Yoriann M. Cabrera Bartolomei. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to establish adequate specifications, sampling plans, and testing procedures to ensure that raw materials and…
- 02
Certificates of analysis from raw material suppliers are accepted in lieu of…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmDr. Reddy's Laboratories (EU) Ltd. Steanard Lane history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dr. Reddy's Laboratories (EU) Ltd. Steanard Lane?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Dr. Reddy's Laboratories (EU) Ltd. Steanard Lane?
Arsen Karapetyan and Yoriann M. Cabrera Bartolomei are named on this Form 483, for the inspection of Sep 1 – Sep 5, 2025. Each investigator has a profile showing what they cite most.
When was Dr. Reddy's Laboratories (EU) Ltd. Steanard Lane inspected by FDA?
The inspection ran Sep 1 – Sep 5, 2025, and the Form 483 is dated September 5, 2025.
How do I get the full Form 483 for Dr. Reddy's Laboratories (EU) Ltd. Steanard Lane?
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.