Key facts
| Firm | Dr. Reddy's Laboratories Limited |
|---|---|
| FEI / inspection ID | 3012414462 |
| Inspection end date | July 18, 2025 |
| Citation count | 5 |
Citations explained
Observation 1 — Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be
Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be sterile are not written. Specifically, Your SOP entitled, "Procedure fo r cleanin~ CbH 4 fa long_ wjth vial fillin &_Jtopp ering and sealing 4 ma chine, r:T( 4 ]capping machine, I h (b)(, system r · iJ(1.§{c~ RABS", SOP- FTll-PR-0 11 8, Version 8. 0, Effective 29-Apr-20 25 ailows t e use of non-stenl e l Cb)l, to clean the surfaces of the r CbH 4j during the end of the batch. There is no statement in the SOP to p ro hibit the inti·o duction or use of non-sterile CbTCl during set up activities. Fmthe1more, the SOP does not specify if the I ,uH4l sanitization agents that are ro utinely used during cleaning the surfaces of the Grade A J-ib CbHj are steril e. According to the GlQbal Head Quality/Phaimacovigilance, there is no ris ecause the surfaces of the Grade A l (b)C, will be decontaminated withI.
Observation 2 — SEE REVERSE OF THIS PAGE EMPLOYEE(S) SI GNATURE Pa tt y p
SEE REVERSE OF THIS PAGE EMPLOYEE(S) SI GNATURE Pa tt y p Kaewussdangkul, I nves t iga t o r Jigar R Pa t el, FDA Cent er Emplo yee · -- =i 0.:8tgne«OM&-3l2S X 04:31: 37 DATE ISSUED 7/ 1 8/202 5 F ORM FDA ~83 ( 09/ 08) PAGE I of? PAGES PREVIOUS EDmON OBSOLEJE INSPECTIONAL OB SERVATIONS
Observation 3 — Equipment used in the manufacture, processing, packing or holding of drng products
Equipment used in the manufacture, processing, packing or holding of drng products is n ot of adequate size to facilitate operations for its inten de d use. Specifically, The l_ ~ System (Equipment ID: CbT<lli!!!_p ment is used in the compoundin~ fl (b)(4t d :I (b)(4l • • • (b} g/mll ~(l Th • {6,(l Q_rocess o Q_ro ucts j m1 ect10n C4 m e eqmpment r \U/\~1wfii c IS cnb cal Q_ro cess parameters. I Cb><1 The; Cb><4 h ystem -· equi12ment was not gualified to verify the egui12 ment caeac ity which can define I Cb><4j I __ CbTC4 This is paii iculaiy more] impo1iant for the hig4er scale CbH co mmercial scale manufacturing batches where the diug (bY{4 phase is processed in Cb)l4l su6-lots each and the risk of accumulation in the tank may lead to can yover 111 I (b
Observation 4 — Examination and testing of samples is not done to assure that in-process
Examination and testing of samples is not done to assure that in-process materials confo1m to specification s. Specifically, Durm • the compound'mg process of I (bY{,4l1 1n·~ect10 • n (b)ldmg/via • 1, the 1. (b)'{,11of the ~ (in-process bulk) during the manufacturmg process is esta6 ISh ed as critical process parameter EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE OF THIS PAGE Pa tt y p Kaewu ssdangkul, I nves t iga t or Jigar R Pa t el, FDA Cent er Employee X -·- - =i 0.:8tgne«OM&-3l2S 04:31: 37 7/18/2025 PAGE 3 of? PAGES FORM FDA ~83 (09/ 08) PREVIOUS EDmON OBSOLEJE INS PEC TIONAL OB SERVATIONS
Observation 5 — Dmg product production and control records, are not reviewed and approved by
Dmg product production and control records, are not reviewed and approved by the quality contro l unit to dete1mine compliance with all estab li shed, approved written procedures before a batch is released or distributed. Specifica lly, A) On 7/10/2025, we observed a microbiologist read (b 1141 air olates that were used to monitor the Grade A environment during the Media fill #. (bY{-4 of the I (bTC1 Line and enter the counts in their electronic Laborato1y Info1mation Management System (LIMS). According to the Microbiology Head, microbial counts are verified by a supervisor to veri fy that counts are accurate. However, the supervisor failed to document the readings during the secon da1y verification despite LIMS having the capability to enter counts to ensure the integrity of the microbial data generated.
What a Form 483 means
A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.
Dr. Reddy’s Laboratories Limited’s FDA history
Argus HQ has recorded 2 total FDA actions tied to Dr. Reddy’s Laboratories Limited: 0 warning letters, 0 recalls, 0 approval records, and 2 Form 483 inspection citations.
Frequently asked questions
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3012414462.
- Is a Form 483 the same as a Warning Letter?
- No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.
- Where can I read the full Form 483?
- The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.
- What is an FDA Form 483?
- A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.
See if this 483 escalates to a warning letter — before your auditor asks.
Free weekly briefing tracks every FDA inspection outcome.
Related enforcement actions
Full FDA history for Dr. Reddy’s Laboratories LimitedCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2025). Form 483 Record: Dr. Reddy's Laboratories Limited, July 18, 2025 — 5 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-dr-reddy-s-laboratories-limited-2025-07-18-3012414462
"Form 483 Record: Dr. Reddy's Laboratories Limited, July 18, 2025 — 5 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-dr-reddy-s-laboratories-limited-2025-07-18-3012414462.
Argus HQ Research. "Form 483 Record: Dr. Reddy's Laboratories Limited, July 18, 2025 — 5 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-dr-reddy-s-laboratories-limited-2025-07-18-3012414462.
@misc{argushq_argushq_ai_483_fda_483_dr_reddy_s_laboratories_limited_2025_07_18_3012414462_2025,
title = {Form 483 Record: Dr. Reddy's Laboratories Limited, July 18, 2025 — 5 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-dr-reddy-s-laboratories-limited-2025-07-18-3012414462},
note = {Accessed: July 15, 2026}
}