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.

Does this Form 483 mean Suzhou Suncadia Biopharmaceuticals Co., Ltd. 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.

FDA Form 483 — Suzhou Suncadia Biopharmaceuticals Co., Ltd. (January 6, 2025)

Key facts

Firm	Suzhou Suncadia Biopharmaceuticals Co., Ltd.
FEI / inspection ID	3015786877
Inspection end date	January 6, 2025
Citation count	3

In short: FDA inspected Suzhou Suncadia Biopharmaceuticals Co., Ltd. in China and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2025-01-06. FDA records classify Suzhou Suncadia Biopharmaceuticals Co., Ltd. as a drug substance intermediate 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.

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 — Procedures designed to prevent microbiological contamination of drug products purporting to be

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not fully established or followed. Specifically, A Your media fill program is not adequately performed to validate the aseptic operations for (1,)(4} • drug product (DP) manufactunng. 1) Aseptic mammcturing operations are not closely simulated to incorporate appropriate, worst- case activities and conditions. According to the most recent process simulation batch records (b><•>and ><"'aseptic assembly of equipment was simulated by only (b><◄>operators. However, observed during filling operation of (b><•up Batch (b>< ◄>on December 31, 2024, were up to (b)< ◄)operators performing distinct equipment assembly activities at multiple locations in the RABS. 2) The current media fill run is designed to have <b> <•>line speeds. Durations for simulating the (b)(◄)line speed, according to_process simulation batches (b><◄> and (b) (4) (b)(4) . were respectively. They do not closely simulate aseptic manufacturing operations intended for (b><•>DP manufacturing. • s:. • 1 . (1>><4 > t· d • d t.

Observation 2 — Appropriate v isual inspection (VI) procedures designed to assure drug product quality

Appropriate v isual inspection (VI) procedures designed to assure drug product quality are n ot fully established. Specifically, A Testing kit used to qualify VI inspectors contains (b)(4) . (b)(4) • defected vials out of a total testing vials. B. (b><•>is observed in majority of vials containing <bl <4>drug produc SEE REVERSE OF THIS PAGE EMPlO'l'l:E(S)SIGNATV~ EMPLOYl:e(8)-NIIJTinE,-..,or'IW>el Ylwel LI, Ph.D., supervisory Chem ist ' . .. fl V' -~ Jlangsong Jiang, Ph.D. Pharmaceutical Scientist )( 1 WV\1l /I ,1 \. f - pA0C,,OU1~ casa.rn! • INSPECTIONAL OBSERVATIONS FOR M FDA4U (Ot.01) (b)(4 MTlll&Wl 01/06/ 2025

Observation 3 — Automatic or electronic equipment, including ccmputers or related systems, are not routinely

Automatic or electronic equipment, including ccmputers or related systems, are not routinely calibrated, inspected, or checked according to written programs designed to assure proper performance. Specifically, A Software settings fori CbH ◄ Non-viable Particle (NVP) monitoring systems were not verified to ensure proper performance after system upgrades. B. <h><◄ >s CADA software validation requirements are not documented, maintained, and updated. SEE REVERSE OF THIS PAGE FORM FDA 41S (01/01) ft,jpL0'1EE(l'.NAMENCJ'll1\.I ,.,,,.., l)poJ Vlwel LI, Ph.D., Supervisory Chemist Jlangsong Jiang, Ph.D. PharmaceutlcalSdlnlllt INSPECTIONAL OBIERV

Suzhou Suncadia Biopharmaceuticals Co., Ltd.’s FDA history

Argus HQ has recorded 1 total FDA action tied to Suzhou Suncadia Biopharmaceuticals Co., Ltd.: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

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.
Does this Form 483 mean Suzhou Suncadia Biopharmaceuticals Co., Ltd. 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.

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Full FDA history for Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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 — Suzhou Suncadia Biopharmaceuticals Co., Ltd. (January 6, 2025) — 3 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-suzhou-suncadia-biopharmaceuticals-co-ltd-2025-01-06-3015786877

MLA

"FDA Form 483 — Suzhou Suncadia Biopharmaceuticals Co., Ltd. (January 6, 2025) — 3 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-suzhou-suncadia-biopharmaceuticals-co-ltd-2025-01-06-3015786877.

Chicago

Argus HQ Research. "FDA Form 483 — Suzhou Suncadia Biopharmaceuticals Co., Ltd. (January 6, 2025) — 3 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-suzhou-suncadia-biopharmaceuticals-co-ltd-2025-01-06-3015786877.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_suzhou_suncadia_biopharmaceuticals_co_ltd_2025_01_06_3015786877_2025,
  title = {FDA Form 483 — Suzhou Suncadia Biopharmaceuticals Co., Ltd. (January 6, 2025) — 3 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-suzhou-suncadia-biopharmaceuticals-co-ltd-2025-01-06-3015786877},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗