Dr. Reddy's Laboratories Limited (Unit II)
Form 483 issued November 19, 2024 · Sangareddy, India
- Inspection
- Nov 13 – Nov 19, 2024
- Observations
- 5
- Pages
- 10
- FEI number
- 3005448030
In short: On November 19, 2024, FDA issued a Form 483 with 5 observations to Dr. Reddy's Laboratories Limited (Unit II) in Sangareddy, Telangana (FEI 3005448030) after an inspection that ran Nov 13 – Nov 19, 2024. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations into product complaints are inadequate to ensure complaint investigations identify appropriate root causes, assess potential…
- 02
There is a failure to ensure that manufacturing processes are maintained…
- 03
The responsibilities and procedures applicable to the quality control unit are not in writing or fully…
- 06
Buildings used in the manufacturing of Intermediates and finished APIs are not maintained in a…
This inspection in context
Questions about this 483
What did FDA find at Dr. Reddy's Laboratories Limited (Unit II)?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Dr. Reddy's Laboratories Limited (Unit II) inspected by FDA?
The inspection ran Nov 13 – Nov 19, 2024, and the Form 483 is dated November 19, 2024.
How do I get the full Form 483 for Dr. Reddy's Laboratories Limited (Unit II)?
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