Key facts
| Firm | Shouguang Fukang Pharmaceutical Co., Ltd. |
|---|---|
| FEI / inspection ID | 3003941038 |
| Inspection end date | February 21, 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 — DEPA RTMENT OF HE ALTH AND HUMAN SERYl CES FOOD Al'ID DRUG
DEPA RTMENT OF HE ALTH AND HUMAN SERYl CES FOOD Al'ID DRUG AD:vllN IST RATION DISTRJCf AtlOR E N- OAT E(S) OF 1,iSPt<, I ION United States Food and Drng Administration 02/17/ 202 5-02/ 2 1/ 2 02 5 12420 Parklawn Dr., Room 2037, Rockville, MD 20857 FEINUM8ER CDER-OC-OMQ-lntem ationa1483Response@fda.hhs.gov 3003941 038 lndustrv lnfonnation: www.fda.1?ov/oc/industrv NAMENIOTITLE O<' INONIDUAI. TOWHOM REPORT ISSUED Mr. Li Hongcheng - Vice Pr e sident flRMMME sTRu: , AO~;:i; Sho uguang Fu kang Ph arma ceut ic al Co ., North - East of Dongwaihuan Road, Dongc heng Ltd. Ind ust rial Area CITY. STAlE. Zf> ~COUNTRY TYPE ESTA&t.lSHtJENT INSPECTEO Shougu an g Ci t y, Sh an do ng , Chi na 262700 API Ma nufa c turer This document lists observations made by the FDA re prcsentative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an obj e.
Shouguang Fukang Pharmaceutical Co., Ltd.’s FDA history
Argus HQ has recorded 1 total FDA action tied to Shouguang Fukang Pharmaceutical Co., Ltd.: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Does this Form 483 mean Shouguang Fukang Pharmaceutical 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.
- Has Shouguang Fukang Pharmaceutical Co., Ltd. had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Shouguang Fukang Pharmaceutical Co., Ltd. so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3003941038.
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Related enforcement actions
Full FDA history for Shouguang Fukang Pharmaceutical 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.
Argus HQ Research (2025). Shouguang Fukang Pharmaceutical Co., Ltd. — FDA Form 483 Inspection, February 21, 2025 (1 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-shouguang-fukang-pharmaceutical-co-ltd-2025-02-21-3003941038
"Shouguang Fukang Pharmaceutical Co., Ltd. — FDA Form 483 Inspection, February 21, 2025 (1 Citations)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-shouguang-fukang-pharmaceutical-co-ltd-2025-02-21-3003941038.
Argus HQ Research. "Shouguang Fukang Pharmaceutical Co., Ltd. — FDA Form 483 Inspection, February 21, 2025 (1 Citations)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-shouguang-fukang-pharmaceutical-co-ltd-2025-02-21-3003941038.
@misc{argushq_argushq_ai_483_fda_483_shouguang_fukang_pharmaceutical_co_ltd_2025_02_21_3003941038_2025,
title = {Shouguang Fukang Pharmaceutical Co., Ltd. — FDA Form 483 Inspection, February 21, 2025 (1 Citations)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-shouguang-fukang-pharmaceutical-co-ltd-2025-02-21-3003941038},
note = {Accessed: July 13, 2026}
}