Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal
Form 483 issued February 28, 2020 · Medchal-Malkajgiri, India
- Investigator
- Frederick Razzaghi
- Observations
- 1
- Pages
- 1
- FEI number
- 3002949099
In short: On February 28, 2020, FDA issued a Form 483 with 1 observation to Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal in Medchal-Malkajgiri, Telangana (FEI 3002949099). The investigator was Frederick Razzaghi. Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
This inspection in context
Frederick Razzaghi
15 documents · 2014–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
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 211.110
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 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal?
Frederick Razzaghi is named on this Form 483. 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?
This Form 483 is dated February 28, 2020.
How do I get the full Form 483 for Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal?
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