Key facts
| Firm | Dr. Reddy’s Laboratories Limited |
|---|---|
| FEI / inspection ID | 3009193040 |
| Inspection end date | December 12, 2025 |
| Citation count | 5 |
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.
Citations explained
Observation 1 — There is a failure to thoroughly review any unexplained discrepancy a its
There is a failure to thoroughly review any unexplained discrepancy a its components to meet any of its specifications whether or not the bat Specifically, A. On 4/28/2025, you recorded non-conformances 310028189 an CES F INSPECTION 4/2025-12/12/2025 ER 193040 ess Unit-01, Devunipalavalasa thalam (Mandal) ED anufacturer
Observation 2 — Control procedures are not established which validate the performance of those manufacturing
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Specifically, you qualified your Tablet Compression Machine ID # PR034 and ID # PR034 in Room as per the Performance Qualification Report FTS1PRPR034-01 (Effective date 8/8/2013). On 3/16/2024 the ID # PR034 underwent breakdown during the manufacturing of Batch No. . You replaced ID # PR034 with a different ID # PR182 and continued with the manufacturing of Batch No. . As of 12/12/2025, you have not requalified your Tablet Compression Machine ID # PR034 and ID # PR182 assembly in Room . The make and model of the ID’s # are different. Your Head of Production stated that the working principles for are same thus requalification is not RAJIV R. Digitally signed by SR IVAST AVA - RAJIV R. SRIVASTAVA-S Date: 2025 . 12.12 s 16:38 :21 +05'30' (b)(4).
Observation 3 — Written procedures are not established for the cleaning and maintenance of equipment
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. Specifically, you practice cleaning validation for equipment trains for the worst-case molecule. The cleaning validation for your Tablet Compression Machine ID # PR034 and ID # PR034 in was conducted in an equipment train for Tablet as the worst-case molecule as reported in Cleaning Validation Report for Tablets VALRP-FS01- 000310 (Effective date 10/6/2020). On 3/16/2024 the ID # PR034 underwent breakdown during the manufacturing of Batch No. . You replaced ID # PR034 with a different ID # PR182. After changing the equipment, you did not re-validate the cleaning of the new equipment train. Your Head of Production ( ) stated that the surface area of PR182 ( 2 ) is higher than PR034 ( 2 ). After multiple requests, you were unable to provide surface area calculations for the ID # PR034 for.
Observation 4 — Testing and release of drug product for distribution do not include appropriate
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release. Specifically, A. Section 5.10.6 of your procedure, SOP-GLOB-QC-0085 Version 13.0 Good Analytical Practices (Effective date 7/25/2025) requires measurements from each preparation for assay test methods by HPLC. However, you have validated the assay test methods by HPLC from a single measurement from each preparation. E. g. a. Tablets USP mg Assay Method Validation Report No. RP-FS01-000060 Version 2.0 (Effective date 3/27/2020). Linearity of test method was established from concentration range μgm/mL – μgm/mL ( % - % of the standard solution) at intervals with a single measurement at each concentration. You routinely use this test method to release Tablets USP mg to the US market. b. in Table mg/ mg, Assay (by HPLC) Method Validation Report No. RP-FS01-002324 Version 1.0 (Effective date 7/11/2024). Linearity of test method was established from concentration range % to % (of.
Observation 5 — Written procedures are not followed for the sampling of drug substance and
Written procedures are not followed for the sampling of drug substance and excipients. RAJIV R. Digitally signed by RAJIV R. SRIVASTAVA- SRIVASTAVA s -5 Date: 2025.12.12 16:40:07 +05'30' (b)(4) (b)(4) (b)(4) (b)(4) (b)(4) (b)(4) (b) (4) (b) (6)(b)(4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (6) (b) (6) (b) (6) (b) (4)
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 happens after a Form 483 is issued?
- The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
- Has Dr. Reddy’s Laboratories Limited had other FDA inspection citations?
- Yes. Argus HQ has recorded 2 total FDA actions tied to Dr. Reddy’s Laboratories Limited, including 2 Form 483 inspection citations.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3009193040.
- 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.
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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). December 12, 2025 FDA Form 483 for Dr. Reddy’s Laboratories Limited — 5 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-dr-reddy-s-laboratories-limited-2025-12-12-3009193040
"December 12, 2025 FDA Form 483 for Dr. Reddy’s Laboratories Limited — 5 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-dr-reddy-s-laboratories-limited-2025-12-12-3009193040.
Argus HQ Research. "December 12, 2025 FDA Form 483 for Dr. Reddy’s Laboratories Limited — 5 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-dr-reddy-s-laboratories-limited-2025-12-12-3009193040.
@misc{argushq_argushq_ai_483_fda_483_dr_reddy_s_laboratories_limited_2025_12_12_3009193040_2025,
title = {December 12, 2025 FDA Form 483 for Dr. Reddy’s Laboratories Limited — 5 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-dr-reddy-s-laboratories-limited-2025-12-12-3009193040},
note = {Accessed: July 15, 2026}
}