Dr. Reddy's Laboratories Limited
Form 483 issued December 8, 2023 · Bachupally, India
- Inspection
- Dec 4 – Dec 8, 2023
- Investigator
- Saleem A. Akhtar
- Observations
- 3
- Pages
- 12
- FEI number
- 3009483004
In short: On December 8, 2023, FDA issued a Form 483 with 3 observations to Dr. Reddy's Laboratories Limited in Bachupally, India (FEI 3009483004) after an inspection that ran Dec 4 – Dec 8, 2023. The investigator was Saleem A. Akhtar. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records are deficient in that they do not include a complete record of all…
- 02
Determinations of conformance to appropriate written specifications for acceptance are…
- 03
Employees are not given training in the particular operations they perform as part of their function…
This inspection in context
Saleem A. Akhtar
35 documents · 2004–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmDr. Reddy's Laboratories Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194
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 3 observations on this Form 483, mostly about laboratory controls and quality system. 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 Limited?
Saleem A. Akhtar is named on this Form 483, for the inspection of Dec 4 – Dec 8, 2023. Each investigator has a profile showing what they cite most.
When was Dr. Reddy's Laboratories Limited inspected by FDA?
The inspection ran Dec 4 – Dec 8, 2023, and the Form 483 is dated December 8, 2023.
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.