Dr Reddy's Laboratories Limited
Form 483 issued August 23, 2024 · Srikakulam, India
- Inspection
- Aug 19 – Aug 23, 2024
- Observations
- 3
- Pages
- 5
- FEI number
- 3009193040
In short: On August 23, 2024, FDA issued a Form 483 with 3 observations to Dr Reddy's Laboratories Limited in Srikakulam, Andhra Pradesh (FEI 3009193040) after an inspection that ran Aug 19 – Aug 23, 2024. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 2 of 3 observations.
Most cited: 21 CFR 211.160 (1×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and standards designed…
- 02
already…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Questions about this 483
What did FDA find at Dr Reddy's Laboratories Limited?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Dr Reddy's Laboratories Limited inspected by FDA?
The inspection ran Aug 19 – Aug 23, 2024, and the Form 483 is dated August 23, 2024.
How do I get the full Form 483 for Dr Reddy's Laboratories Limited?
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.