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 Zydus Lifesciences Limited 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.

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

FEI / inspection ID: 3005430968.

FDA Form 483 — Zydus Lifesciences Limited (August 13, 2025)

Here's the summary: FDA inspected Zydus Lifesciences Limited in India and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2025-08-13. FDA records classify Zydus Lifesciences Limited as a 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	Zydus Lifesciences Limited
FEI / inspection ID	3005430968
Inspection end date	August 13, 2025
Citation count	3

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 — The responsibilities and procedures applicable to the qua li ty control unit

The responsibilities and procedures applicable to the qua li ty control unit are not fully fo llowed. Specifica lly, your quality unit did not to take appropriate market action for batches of US product that failed to meet the specification limit for I (b)l1 Dmg Substance Related Impuritie~ (b)l1 For example: I CbTC 4l out of (b)l~batches of CbTC 4l Tablets USP failed to m~et the . . . . (b)(4 (b)(4) . . . (b)(4 . specification hm 1t of ppm fo 1 ·i 1mpun bes when analyzed as p a1t of a I '1n sk assessment in l (b><4j A few examples are listed as fo llows: Batch Product Manufacturing Expiry date Age of sampl~~~ lts for No.: Strength date when analyze~ (b)l1 (ppm) i (bf{,\1 (b114l

Observation 2 — Procedures describing the handling of written and oral complaints related to diug

Procedures describing the handling of written and oral complaints related to diug products are de fi ciently written or fo llowed. Specifically, your Quality Unit fail ed to thoroughly investigate adverse diug event (ADE) relating to patient death. For example, A. On 21-Feb-2023, your fnm initiated ADE No.: AE/0302/20 23 /0016 upon receiving complaint from a Physician regarding a male patient death in the US that was on your I (bY{-41 mg Tablets fo r the treatment of l (b)l1 According to the description of ADE complaint, Physician stat ed over the phone call that she will email further details relating to this event to share batch number, product NDC number and so on to assist with the site investigatio n. However, your fnm neither made sufficient attempt to know the batch number nor tried to collect the complaint sample which is required per your ADE handling procedures SOP-ZUSA-0005, R evision: 08 and 0302- SOP-QA-00036, Version: 5.0. In the absence.

Observation 3 — Reserve samples from representative sample lots or batches of diu g products

Reserve samples from representative sample lots or batches of diu g products selected by acceptable statistical procedures are not examined visually at least once a year fo r evidence of deterioration. Specifically, Reserve (Retain) samples of di11g products are examined based on Accep ta ble Quality Level (AQL) Inspector 's Rule and Inspection Manua l. This practice does not consi de r enhanced examination when several repeated product qualif come laints pe1iaining to ta blets discoloration, broken tablets, disintegrated tablets, tablets with : {6fj bigger tablets, foreign matters, count variability are SEE REVERSE OF THIS PAGE

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 Zydus Lifesciences Limited 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.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3005430968.

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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 (August 13, 2025) — 3 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-zydus-lifesciences-limited-2025-08-13-3005430968

MLA

"FDA Form 483 — Zydus Lifesciences Limited (August 13, 2025) — 3 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-zydus-lifesciences-limited-2025-08-13-3005430968.

Chicago

Argus HQ Research. "FDA Form 483 — Zydus Lifesciences Limited (August 13, 2025) — 3 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-zydus-lifesciences-limited-2025-08-13-3005430968.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_zydus_lifesciences_limited_2025_08_13_3005430968_2025,
  title = {FDA Form 483 — Zydus Lifesciences Limited (August 13, 2025) — 3 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-zydus-lifesciences-limited-2025-08-13-3005430968},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗