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 had other FDA inspection citations?

Yes. Argus HQ has recorded 2 total FDA actions tied to Lupin Limited, including 2 Form 483 inspection citations.

What is the FEI / inspection ID for this Form 483?

FEI / inspection ID: 3015392060.

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.

September 16, 2025 FDA Form 483 for Lupin Limited

Here's the summary: FDA inspected Lupin Limited in India and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2025-09-16. FDA records classify Lupin Limited as a sterile 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.

Key facts

Firm	Lupin Limited
FEI / inspection ID	3015392060
Inspection end date	September 16, 2025
Citation count	1

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 DISTRICT ADDRESS

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMBER 12 4 20 Parklawn Drive, Room 2032 Rockville, MD 20857 OATE(S) OF INSPECTION 9/8/2025 - 9/16/2025* FEJNUMBER 3015392060 NAM E AND TITLE OF INOMOUAL TO WHOM REPORT ISSU ED Ranjana Pathak, President & Chief Quali ty Officer Corpora te Quali ty Assurance FIRM NAME Lupin Limi ted STREET ADDRESS Uni t - 2 Plot No. 6B, Sec t or - 17, Special Economic Zone, Mihan CITY. STATE. ZIP CODE. COUNTRY Nagpur, Maharash tra, 441108 India TYPE ESTABUSI-NE NT INSPECTED S teri le Manufac t urer This document lists ob servations made by the FDA representative(s) during the inspection of your facility. They are i

Lupin Limited’s FDA history

Argus HQ has recorded 2 total FDA actions tied to Lupin 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 Lupin Limited had other FDA inspection citations?: Yes. Argus HQ has recorded 2 total FDA actions tied to Lupin Limited, including 2 Form 483 inspection citations.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3015392060.
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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Full FDA history for Lupin Limited

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). September 16, 2025 FDA Form 483 for Lupin Limited — 1 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-lupin-limited-2025-09-16-3015392060

MLA

"September 16, 2025 FDA Form 483 for Lupin Limited — 1 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-lupin-limited-2025-09-16-3015392060.

Chicago

Argus HQ Research. "September 16, 2025 FDA Form 483 for Lupin Limited — 1 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-lupin-limited-2025-09-16-3015392060.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_lupin_limited_2025_09_16_3015392060_2025,
  title = {September 16, 2025 FDA Form 483 for Lupin Limited — 1 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-lupin-limited-2025-09-16-3015392060},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗