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

FEI / inspection ID: 3013712903.

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.

FDA Form 483 — Zydus Lifesciences Limited (September 5, 2025)

Key facts

Firm	Zydus Lifesciences Limited
FEI / inspection ID	3013712903
Inspection end date	September 5, 2025
Citation count	1

The short version: FDA inspected Zydus Lifesciences Limited in India and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2025-09-05. FDA records classify Zydus Lifesciences 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.

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 — C DEPARTMENT Of HEAlTH ANO HUMAN SEIIVIClS

C DEPARTMENT Of HEAlTH ANO HUMAN SEIIVIClS ,.... ., ,., r UG~~., ~MIIAflON 0U5,lft!\.1 AOOftt I A"ftH """~'" ..... """'12420 1',tr\,.la\\ll Om c. Room 2032 ROI.I,, Ille, t\.lD 20857 ..,,., .,._,, r ..... ,., .. .Mr Mitc\h 1--.. t-,,lchla. C'h1ct -ManulJcturing JIIU,r,"""*- /) du!> L1fc\cicnccs I 11111ted IIT"T{ ,...(.. (.."'""""' \ladodam. (,ujar,u.391510. India SEE REVERSE OF THIS ~w~ I ~~ PAGE ~ FORM FDA OJ (01/GI/ ,- n..c)~ fOllO. 01:SOtf'"'E l h1' document li~b ob!>cn.iuon-; made b) the I DA rcprc,cnta\l\e(\) during the m,pection of )OUr fad ht) . I he) arc m~pcctional ob~e,, auom,. and do not n:pre,cnt a linal A gene) dc1cr111ma11on regarding )Our compliance. If ) ou ha\C an ob1cction regarding an oh,er\,1tion. or hJ\C implemented. or plan to implement, corn..-ct1 ~c action in rcspon~c to an obscn ation. )OU ma) di\cu~, the ob_1ection or action ,,ith the I DA rcprl.~entau,C(s) during the inspection or submit th1,; infbm1at1on to I-Di\ al the addre~, abm,c. It )OU ha,c.

Frequently asked questions

What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3013712903.
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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Full FDA history for Zydus Lifesciences 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). FDA Form 483 — Zydus Lifesciences Limited (September 5, 2025) — 1 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-zydus-lifesciences-limited-2025-09-05-3013712903

MLA

"FDA Form 483 — Zydus Lifesciences Limited (September 5, 2025) — 1 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-zydus-lifesciences-limited-2025-09-05-3013712903.

Chicago

Argus HQ Research. "FDA Form 483 — Zydus Lifesciences Limited (September 5, 2025) — 1 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-zydus-lifesciences-limited-2025-09-05-3013712903.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_zydus_lifesciences_limited_2025_09_05_3013712903_2025,
  title = {FDA Form 483 — Zydus Lifesciences Limited (September 5, 2025) — 1 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-zydus-lifesciences-limited-2025-09-05-3013712903},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗