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.

Does this Form 483 mean Lupin Limited Unit 2 violated the law?

No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.

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 Lupin Limited Unit 2 had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for Lupin Limited Unit 2 so far. Argus ingests new FDA records daily.

FDA Inspects Lupin Limited Unit 2: Form 483 with 1 Citations (July 17, 2025)

Key facts

Firm	Lupin Limited Unit 2
FEI / inspection ID	3007549629
Inspection end date	July 17, 2025
Citation count	1

Key takeaway: FDA inspected Lupin Limited Unit 2 in India and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2025-07-17. FDA records classify Lupin Limited Unit 2 as a human drug manufacturer. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record.

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 — DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTR ICT

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTR ICT ADDRESS ANO PHONE NUMBER 1 2 4 20 Parklawn Drive, Room 20 32 Rockville, MD 20857 DATE(S) OF INSPECTI ON 7/8/2025 - 7/ 1 7/2025* FEJ NUMBER 3007549629 NAME ANO TmE OF INDIVIDUAL TO WHOM REPORT ISSUED Amit Sareen, Site Head and Sr. Vice President - Manufacturing FIRM NAME Lupin Limited STREET AOORESS Unit - 2, Plot No . M- 2 & M- 2 - A, SEZ, Phase II, MISC. Zone, Apparel Park, Dis t. Dha r CITY. STATE. ZIP CODE. COUNTRY Pithampur, Madhya Pradesh, 454775 India TYPE ESTABLI SHMENT INSPECTED Human Drug Manufacturer This document lists observations made by the FDA representative(s) dtu-ing the inspection of yotu· facility. They are inspectional observations, and do not represent a final Agency detel'lllination regarding yotu· compliance. If you have an objection regarding an observation, or have in1plemented, or plan to implement, corrective action in response to an observation, you may.

Lupin Limited Unit 2’s FDA history

Argus HQ has recorded 1 total FDA action tied to Lupin Limited Unit 2: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

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.
Does this Form 483 mean Lupin Limited Unit 2 violated the law?: No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.
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 Lupin Limited Unit 2 had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Lupin Limited Unit 2 so far. Argus ingests new FDA records daily.

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Full FDA history for Lupin Limited Unit 2

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.

APA

Argus HQ Research (2025). FDA Inspects Lupin Limited Unit 2: Form 483 with 1 Citations (July 17, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-lupin-limited-unit-2-2025-07-17-3007549629

MLA

"FDA Inspects Lupin Limited Unit 2: Form 483 with 1 Citations (July 17, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-lupin-limited-unit-2-2025-07-17-3007549629.

Chicago

Argus HQ Research. "FDA Inspects Lupin Limited Unit 2: Form 483 with 1 Citations (July 17, 2025)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-lupin-limited-unit-2-2025-07-17-3007549629.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_lupin_limited_unit_2_2025_07_17_3007549629_2025,
  title = {FDA Inspects Lupin Limited Unit 2: Form 483 with 1 Citations (July 17, 2025)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-lupin-limited-unit-2-2025-07-17-3007549629},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗