FDA-Inspected Site

Dr Reddy's Laboratories Limited

7 FDA inspections are on record for Dr Reddy's Laboratories Limited in Devunipalavalasa, India.

483· Form 483 issued

Devunipalavalasa, India · Last updated July 9, 2026

Overview

  • 7 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-12-12.

At a glance

Inspections

7

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 Dec 2025 – 12 Dec 2025Human Drugs483On file
19 Aug 2024 – 23 Aug 2024Human Drugs483On file
10 Feb 2020 – 14 Feb 2020Human DrugsClean
7 Jan 2019 – 15 Jan 2019Human Drugs483View 483 →
12 Jun 2017 – 16 Jun 2017Human Drugs483On file
18 Jan 2016 – 22 Jan 2016Human Drugs483On file
10 Nov 2014 – 14 Nov 2014Human DrugsClean

Observations on record

Form 483 observations cited at this site, most recent first.

15 Jan 2019
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Justin A Boyd, Rumany C Penn

15 Jan 2019
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Justin A Boyd, Rumany C Penn

15 Jan 2019
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Justin A Boyd, Rumany C Penn

15 Jan 2019
21 CFR 211.68(b)

Computer control of master formula records

Cited by Justin A Boyd, Rumany C Penn

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Dr Reddy's Laboratories Limited's 5 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat