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

FEI / inspection ID: 3008654585.

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.

SMS Pharmaceutical Limited - Unit VII — FDA Form 483 Inspection, December 12, 2025 (1 Citations)

Here's the summary: FDA inspected SMS Pharmaceutical Limited - Unit VII in India and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2025-12-12. FDA records classify SMS Pharmaceutical Limited - Unit VII as a api (animal origin) 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	SMS Pharmaceutical Limited - Unit VII
FEI / inspection ID	3008654585
Inspection end date	December 12, 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 — Failure to ens ure that all sp ecifications are sc ientifi cally

Failure to ens ure that all sp ecifications are sc ientifi cally sound and appropriate to ensure that your API confo1m to establish ed standards of quality and, or pmity. Specifi cally, The established criteria for extraneous matter testing is not followed. The General Test Procedure for extraneous matter (GTP/QC/018 Version 03 Effective 17OCT2025) has the established specifications bel ow : (b) (4) The procedure states to test b,><4> d your fnm test ed b,><4> I for each batch. Your fnm did n ot use the resulting paii icle count from ~><4> to dete1mine the particle count per ~><4> Ifor the ~ establish ed specifications. For exam ple, the in-hou se batch number b,><4> Jfor active phaima ceutical ingredien \~"A) I USP was tested for extraneous matter on 11DEC2025. The result for ~><4> I was repo1ie d as~~ 1 paiiicles and pass ing. However, the result isi<t>> paiiicles for ~><4> Iw hi ch would be a failing resul t. This.

SMS Pharmaceutical Limited - Unit VII’s FDA history

Argus HQ has recorded 1 total FDA action tied to SMS Pharmaceutical Limited - Unit VII: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3008654585.
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 SMS Pharmaceutical Limited - Unit VII

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). SMS Pharmaceutical Limited - Unit VII — FDA Form 483 Inspection, December 12, 2025 (1 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-sms-pharmaceutical-limited-unit-vii-2025-12-12-3008654585

MLA

"SMS Pharmaceutical Limited - Unit VII — FDA Form 483 Inspection, December 12, 2025 (1 Citations)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-sms-pharmaceutical-limited-unit-vii-2025-12-12-3008654585.

Chicago

Argus HQ Research. "SMS Pharmaceutical Limited - Unit VII — FDA Form 483 Inspection, December 12, 2025 (1 Citations)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-sms-pharmaceutical-limited-unit-vii-2025-12-12-3008654585.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_sms_pharmaceutical_limited_unit_vii_2025_12_12_3008654585_2025,
  title = {SMS Pharmaceutical Limited - Unit VII — FDA Form 483 Inspection, December 12, 2025 (1 Citations)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-sms-pharmaceutical-limited-unit-vii-2025-12-12-3008654585},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗