DR.REDDY'S Laboratories LIMITED
Form 483 issued May 17, 2024 · Visakhapatnam, India
- Inspection
- May 8 – May 17, 2024
- Investigator
- Michael A. Charles
- Observations
- 2
- Pages
- 3
- FEI number
- 3006549835
In short: On May 17, 2024, FDA issued a Form 483 with 2 observations to DR.REDDY'S Laboratories LIMITED in Visakhapatnam, Andhra Pradesh (FEI 3006549835) after an inspection that ran May 8 – May 17, 2024. The investigator was Michael A. Charles. 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 2 of 2 observations.
Most cited: 21 CFR 211.113(b) (1×) · 211.67(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmDR.REDDY'S Laboratories LIMITED 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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DR.REDDY'S Laboratories LIMITED?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. 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 LIMITED?
Michael A. Charles is named on this Form 483, for the inspection of May 8 – May 17, 2024. Each investigator has a profile showing what they cite most.
When was DR.REDDY'S Laboratories LIMITED inspected by FDA?
The inspection ran May 8 – May 17, 2024, and the Form 483 is dated May 17, 2024.
How do I get the full Form 483 for DR.REDDY'S Laboratories LIMITED?
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