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 Shilpa Medicare Limited had other FDA inspection citations?

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

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

FEI / inspection ID: 3009876430.

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.

November 21, 2025 FDA Form 483 for Shilpa Medicare Limited

Here's the summary: FDA inspected Shilpa Medicare Limited in India and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2025-11-21. FDA records classify Shilpa Medicare 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	Shilpa Medicare Limited
FEI / inspection ID	3009876430
Inspection end date	November 21, 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 — Aseptic processing areas are deficient regarding the system fo r cleaning and

Aseptic processing areas are deficient regarding the system fo r cleaning and disinfecting the equipment to produce aseptic conditions. Specifically, I CbH.il> I used in the manufacture of j CbH.il> JInjection, 'lb)<">mg/vial,._is n ot 4 composed of smooth and cleanable surfaces. During r eview of the inside of the clean I CbH >7 the fo llowing was observed: CbH",-, • tb)<"ldi • hI gh h • 'd f h i Cb)<">---, £ 1 f h d A. ..----,--I contams ·ams t ·o u out t e ms1 e o t e _1 __I or remova o t e spraye CbH 4 > water used during cleaning. The inside of these di·ains are never clean ed or monitored fo r microbial growth. B. The manufacturer of the (6H~ is 1 (6H~ while manufacture of the filling machine is i Cb><4 T • h CbH4> h' 1k l'k • 1 d • 'd h r Cb><4>---, Th ' I o mtegrate t.

Observation 2 — There is a failure to thoroughly review any unexplained discrepancy and the

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been ah-eady distributed. Specifically, 4 4 A. r urin~ the manu facture of (b) <> ~ iection (b) < 4 > mg/vial Batch l (b)( >--i_12 l ow~~ (bH4> 1 ·d ·fi d • hin h (b)(4> 1 d. g1 1 d. To • a aims were 1 enb 1e wit t e oa m un oa mg conveyor. e impact assessment fo1m completed for these excursions stated no impact on product quality as these ~1 1 CbH 4 >7 alaims observed for fraction of seconds, all other parameters were within limit, and the process repo1i was reviewed and fmmd satisfacto1y. The impact assessment is deficient since at least 5 alaims were obser ved fo r over one minute (including an alaim up to 26 minutey i~.

Observation 3 — Laborato1y controls do n ot include the establis hment of sc ientifically

Laborato1y controls do n ot include the establis hment of sc ientifically sound and appropriate specifications and test procedures d es ign ed to assure that comp onents and diug products confo 1m to appropriate standards of identity, strength, quality and purity. Specifically, A. Your fnm failed to provide complete method equivalency study comparing_your in-house 4 analytical test meth od to the compendia! meth od for detecting r (b) ( ) I4 4 4 (6 r (bl( ) in )( ) l Your fnm only provided an interim repo1t ofl (b)( ) testmg lll 4 4 I CbX > I(Doc# S ML 71Cb>< '7 AMV1REPORT/ 00 17-00). The interim repo1t was generated by your contracting laborato1y who does product release test. The interim repo1t only doc uments failure to perfo 1m the compendia! meth od ; No comparative data or statistical analysis between your in-house meth od and the com pendia! meth od was provided to demonstrate equivalency or non-inferiority..

Shilpa Medicare Limited’s FDA history

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

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 Shilpa Medicare Limited had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Shilpa Medicare Limited so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3009876430.
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 Shilpa Medicare 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). November 21, 2025 FDA Form 483 for Shilpa Medicare Limited — 3 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-shilpa-medicare-limited-2025-11-21-3009876430

MLA

"November 21, 2025 FDA Form 483 for Shilpa Medicare Limited — 3 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-shilpa-medicare-limited-2025-11-21-3009876430.

Chicago

Argus HQ Research. "November 21, 2025 FDA Form 483 for Shilpa Medicare Limited — 3 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-shilpa-medicare-limited-2025-11-21-3009876430.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_shilpa_medicare_limited_2025_11_21_3009876430_2025,
  title = {November 21, 2025 FDA Form 483 for Shilpa Medicare Limited — 3 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-shilpa-medicare-limited-2025-11-21-3009876430},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗