Key facts
| Firm | Strides Pharma Science Limited |
|---|---|
| FEI / inspection ID | 3004554612 |
| Inspection end date | May 20, 2026 |
| 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 — -- 1 of 17 -- -- 2 of 17 -- -- 3 of 17 -- -- 4 of 17 -- -- 5 of 17 -- -- 6 of 17 -- -- 7
-- 1 of 17 -- -- 2 of 17 -- -- 3 of 17 -- -- 4 of 17 -- -- 5 of 17 -- -- 6 of 17 -- -- 7 of 17 -- -- 8 of 17 -- -- 9 of 17 -- -- 10 of 17 -- -- 11 of 17 -- -- 12 of 17 -- -- 13 of 17 -- -- 14 of 17 -- -- 15 of 17 -- -- 16 of 17 -- -- 17 of 17 -- 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. 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.
Strides Pharma Science Limited’s FDA history
Argus HQ has recorded 1 total FDA action tied to Strides Pharma Science Limited: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Does this Form 483 mean Strides Pharma Science 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 Strides Pharma Science Limited had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Strides Pharma Science Limited so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3004554612.
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Related enforcement actions
Full FDA history for Strides Pharma Science Limited- 483 inspection (recent): Mixlab WI LLC -- FDA 483: 1 observation (2026-05-01) →
- 483 inspection (recent): Alvotech Hf -- FDA 483: 1 observation (2026-05-08) →
- 483 inspection (recent): Sincerus Florida, LLC -- FDA 483: 5 observations (2026-05-29) →
- 483 inspection (recent): Lt Col Luke Weather Jr Veterans Affairs Medical Center -- FDA 483: 6 observations (2026-06-04) →
- 483 inspection (recent): Denver Solutions LLC dba Leiters Health -- FDA 483: 1 observation (2026-06-08) →
- 483 inspection (recent): Annovex Pharma Inc -- FDA 483: 1 observation (2026-07-03) →
- 483 inspection (recent): Turbare Manufacturing -- FDA 483: 4 observations (2026-07-07) →
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.
Argus HQ Research (2026). FDA Inspects Strides Pharma Science Limited: Form 483 with 1 Citations (May 20, 2026). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/strides-pharma-science-limited-3004554612-2026-05-20
"FDA Inspects Strides Pharma Science Limited: Form 483 with 1 Citations (May 20, 2026)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/strides-pharma-science-limited-3004554612-2026-05-20.
Argus HQ Research. "FDA Inspects Strides Pharma Science Limited: Form 483 with 1 Citations (May 20, 2026)." Digital Empire Holdings LLC. Accessed July 29, 2026. https://argushq.ai/483/strides-pharma-science-limited-3004554612-2026-05-20.
@misc{argushq_argushq_ai_483_strides_pharma_science_limited_3004554612_2026_05_20_2026,
title = {FDA Inspects Strides Pharma Science Limited: Form 483 with 1 Citations (May 20, 2026)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/483/strides-pharma-science-limited-3004554612-2026-05-20},
note = {Accessed: July 29, 2026}
}
