Key facts
| Firm | Sun Pharmaceutical Industries Ltd. |
|---|---|
| FEI / inspection ID | 3002809586 |
| Inspection end date | June 13, 2025 |
| Citation count | 2 |
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 — Your fom failed to establish adequate written procedures for production and process
Your fom failed to establish adequate written procedures for production and process controls design ed to assure that the diug products have the identity, strength, purity, and quality that they are purported or represented to possess. 1. Multiple black particles, difficult to see and appearing after a peri od of settling, resulted in the • • f £ I (b)(-0 In' • b h L (b)(-0 r e1ect1o n o our ~ ~ect1o n ate es ~ I CbH4j The source oftliese paii1c es was dete1mined to 6e "'"fil hng eqmpment. Tliefum fa1 ed to: SEE REVERSE OF THIS PAGE EMPLOYE E($) SIGNATURE Justin A Boyd, Investigator Pratik S Upadhyay, Investigator - Dedicated Drug Cadre X Lisa L Flores, Office of Global Policy and Strategy Employee ..ld'!Aecr 2000358686 ~ : 06-13-2025 T 13:-U DATE lSSUEO 6/ 1 3/2025
Observation 2 — Laborato1y controls do not include the establishment of scientifically sound and appropriate
Laborato1y controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that diug products confo1m to appropriate standards of identity, strength, quality and purity. The procedure SOP028225 relating to the transfer of analytical test methods from your offsite facilities (Transfening Unit (TU)) to your Quality Control Laboratories at the site (Receiving Unit (RU)) are deficient. According to section 5.6.6.3 "Direct Transfer - Two-Way Approach" of SOP028225, Analyst from TU analyzed sample at RU laborato1y utilizing the same equipment, reagents, reference standards, and HPLC column that were later utilized by Analyst of your RU laborato1y. There is no variable involved in analysis conducted by both the Analysts to ensure transfer of method is accurate and reliable. Your transfer of analytical methods resembled like analyst qualification and retest analysis that n01mally involves the use of same sample, reagent, equipment, column, and reference standard. This was observed relating to the transfer of the following analytical test procedure.
Frequently asked questions
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3002809586.
- 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.
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Compiled 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). FDA Inspects Sun Pharmaceutical Industries Ltd.: Form 483 with 2 Citations (June 13, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-sun-pharmaceutical-industries-ltd-2025-06-13-3002809586
"FDA Inspects Sun Pharmaceutical Industries Ltd.: Form 483 with 2 Citations (June 13, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-sun-pharmaceutical-industries-ltd-2025-06-13-3002809586.
Argus HQ Research. "FDA Inspects Sun Pharmaceutical Industries Ltd.: Form 483 with 2 Citations (June 13, 2025)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-sun-pharmaceutical-industries-ltd-2025-06-13-3002809586.
@misc{argushq_argushq_ai_483_fda_483_sun_pharmaceutical_industries_ltd_2025_06_13_3002809586_2025,
title = {FDA Inspects Sun Pharmaceutical Industries Ltd.: Form 483 with 2 Citations (June 13, 2025)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-sun-pharmaceutical-industries-ltd-2025-06-13-3002809586},
note = {Accessed: July 15, 2026}
}