Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal
Form 483 issued October 27, 2023 · Medchal - Malkajgiri, India
- Inspection
- Oct 19 – Oct 27, 2023
- Investigators
- Pratik S. Upadhyay· Saleem A. Akhtar
- Observations
- 10
- Pages
- 23
- FEI number
- 3002949099
In short: On October 27, 2023, FDA issued a Form 483 with 10 observations to Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal in Medchal - Malkajgiri, India (FEI 3002949099) after an inspection that ran Oct 19 – Oct 27, 2023. The investigators were Pratik S. Upadhyay and Saleem A. Akhtar. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and quality system account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Detenninations of confonnance to appropriate written specifications for acceptance are…
- 04
India There is a failure to thoroughly review any unexplained discrepancy and the failure of a…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmDr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. 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 Ltd. No 41 Bachupally Village & Mandal?
Pratik S. Upadhyay and Saleem A. Akhtar are named on this Form 483, for the inspection of Oct 19 – Oct 27, 2023. Each investigator has a profile showing what they cite most.
When was Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal inspected by FDA?
The inspection ran Oct 19 – Oct 27, 2023, and the Form 483 is dated October 27, 2023.
How do I get the full Form 483 for Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal?
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.