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 Intas Pharmaceutical 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.

Has Intas Pharmaceutical Limited had other FDA inspection citations?

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

Intas Pharmaceutical Limited — FDA Form 483 Inspection, September 17, 2025 (3 Citations)

Here's the summary: FDA inspected Intas Pharmaceutical Limited in India and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2025-09-17. FDA records classify Intas Pharmaceutical Limited as a drug product 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	Intas Pharmaceutical Limited
FEI / inspection ID	3005890633
Inspection end date	September 17, 2025
Citation count	3

Citations explained

Observation 1 — There is a failure to thoroughly review any unexplained discrep ancy whether

There is a failure to thoroughly review any unexplained discrep ancy whether or n ot the batch has been ah eady distributed. Specifically, A. Shelf-life of the diug product <6>< 4 > Tablets USP is not ade uately su e: 01ted • h b ·1· da F 1 fi • d (b)<4 > (bH4 > wit sta 11 ta . or exam e your nm ass 1gne a. shelf-life of lbX4) (b)(4) (bH4 > you (b><4 > th_e (bH4 > shelf-life of thi_s Qroduct to (b><4 > in (b><4 > ,(<=: hange Control # DND/ CE1)(b>< 4 > /0674). Again, you (bH 4 > the shelf-life of this product to 4 lbH4 > on (b><4 > (Change Control # DND/CRI) (bH > 0697). Despite having a~justed the shelf-life twice ahe ady, you fmt her (b>< 4 > the shelf-life of this product to t6>< 4 > on (bH 4 > (b)(4 shelf-life could not be adequately suppo1ted by stability studies.

Observation 2 — The responsibilities and procedures applicable to the quality control unit are not

The responsibilities and procedures applicable to the quality control unit are not in writing and fully fo llowed. Specifically, A. Signed electi·onic batch records have been modified without recording any Quality Management System (QMS) events. These actions have been taken with the help of the electi·onic batch record software vendor through email and telephone communications. You have also fail ed to maintain complete electi·onic communications by employees requesting changes to completed and signed batch records and no policy is in place to maintain such communication recor ds. These insti11ctions for changing official GMP records were handl ed and discussed by multiple QA employees with their individual Intas email IDs and group Intas email IDs with shar ed passwor ds. For example, 4 1. On I (b)(4) I QA employee tl,)(6) sent an email to the r (b)( )1 ( electi·onic batch record) software vendor with a message, "As discussed, pls do the needful fo r BPCR" (Batch Production Con ti·o.

Observation 3 — Batch production and control records do not include complete in fo1mation relating

Batch production and control records do not include complete in fo1mation relating to the production and control of each batch. Specifically, (bJ(4) I suspensiont6H4 > mg/mL, batch record for batch # 1 <bl!4> 1 (b)(4) Iwas repo1ied as initiated manu facturing on 7 Febm aiy 2022 and later cancelled after dispens ing of materials. However, this batch record was n ot available fo r revi ew and the fnm claim ed it is missing and could not be traced. No deviation was raised on this issu e. This batch was initially intended to be the second validation batch in a series of three batche) (b)(4) I The actual submitted batches I Cb>< 4 > Also, it should be noted that the three submitted batches did not have the same quantities of A Pis added (b) (4) r I (bJ(4) EMPLO YEE(S) S/GNA TURE EMPLO YEE(S) NAMEAND TTTLE (Print or Type} OATElSSUEO Tamil Digitally signed 09/ 17 /2025 SEE by Tamil.

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.

Intas Pharmaceutical Limited’s FDA history

Argus HQ has recorded 1 total FDA action tied to Intas Pharmaceutical Limited: 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 Intas Pharmaceutical 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.
Has Intas Pharmaceutical Limited had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Intas Pharmaceutical Limited so far. Argus ingests new FDA records daily.

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Full FDA history for Intas Pharmaceutical 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). Intas Pharmaceutical Limited — FDA Form 483 Inspection, September 17, 2025 (3 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-intas-pharmaceutical-limited-2025-09-17-3005890633

MLA

"Intas Pharmaceutical Limited — FDA Form 483 Inspection, September 17, 2025 (3 Citations)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-intas-pharmaceutical-limited-2025-09-17-3005890633.

Chicago

Argus HQ Research. "Intas Pharmaceutical Limited — FDA Form 483 Inspection, September 17, 2025 (3 Citations)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-intas-pharmaceutical-limited-2025-09-17-3005890633.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_intas_pharmaceutical_limited_2025_09_17_3005890633_2025,
  title = {Intas Pharmaceutical Limited — FDA Form 483 Inspection, September 17, 2025 (3 Citations)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-intas-pharmaceutical-limited-2025-09-17-3005890633},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗