Key facts
| Firm | Zhejiang Huahai Pharmaceutical Co., Ltd. |
|---|---|
| FEI / inspection ID | 3003999190 |
| Inspection end date | April 16, 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 — DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT OFFICE
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT OFFICE ADDRESS AND PHONE NUMBER OATE(S) OF INSPECTION January 16-17, and 20-24, 2025 I 2420 Parklawn Drive, Room 2032 Rockville, MD 20857 lnduslly Information: www.fda.gov/oc/industry NAYE AND TITLE OF INDVIOUAL TO VVHOM REPORT "'1s""1s"'s"'"'uE"'O;--- TO: Lihong Lin, Corporate Vice President FIRM NAME STREET ADDRESS Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao CITY, STATE ANO ZlP CODE TYPE OF ESTABLISH\AENT INSPECTED Linhai, Zhejiang 317024, China IDrug Manufacturer THIS DOCUMENT LISTS OBSERVATIONS MADE BY THE FOA REPRESENTATIVE(S) DURII\G THE INSPECTION OF YOUR FACILITY. THEY ARE INSPECTIONAL OBSERVATIONS; AND 00 NOT REPRESENT A FINAL AGENCY DETERMINATION REGARDING YOUR COMPLIANCE. IF YOU HAVE AN OBJECTION REGARDING AN OBSERVATION, OR HAVE IMPLEMENTED, OR PLAN TO IMPLEMENT CORRECTIVE ACTION IN RESPONSE TO AN OBSERVATION, YOU MAY DISCUSS THE OBJECTION OR ACTION WITH THE FDA REPRESENTATIVE($) DURING THE INSPECTION OR SUBMIT THIS INFORMATION TO FDA AT THE AOORESS ABOVE IF YOU HAVE Alff QUESTIONS, PLEASE CONTACT FDA.
Zhejiang Huahai Pharmaceutical Co., Ltd.’s FDA history
Argus HQ has recorded 2 total FDA actions tied to Zhejiang Huahai Pharmaceutical Co., Ltd.: 0 warning letters, 0 recalls, 0 approval records, and 2 Form 483 inspection citations.
Frequently asked questions
- 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 Zhejiang Huahai 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 Zhejiang Huahai Pharmaceutical Co., Ltd. had other FDA inspection citations?
- Yes. Argus HQ has recorded 2 total FDA actions tied to Zhejiang Huahai Pharmaceutical Co., Ltd., including 2 Form 483 inspection citations.
See if this 483 escalates to a warning letter — before your auditor asks.
Free weekly briefing tracks every FDA inspection outcome.
Related enforcement actions
Full FDA history for Zhejiang Huahai 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). Zhejiang Huahai Pharmaceutical Co., Ltd. — FDA Form 483 Inspection, April 16, 2025 (1 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-zhejiang-huahai-pharmaceutical-co-ltd-2025-04-16-3003999190
"Zhejiang Huahai Pharmaceutical Co., Ltd. — FDA Form 483 Inspection, April 16, 2025 (1 Citations)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-zhejiang-huahai-pharmaceutical-co-ltd-2025-04-16-3003999190.
Argus HQ Research. "Zhejiang Huahai Pharmaceutical Co., Ltd. — FDA Form 483 Inspection, April 16, 2025 (1 Citations)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-zhejiang-huahai-pharmaceutical-co-ltd-2025-04-16-3003999190.
@misc{argushq_argushq_ai_483_fda_483_zhejiang_huahai_pharmaceutical_co_ltd_2025_04_16_3003999190_2025,
title = {Zhejiang Huahai Pharmaceutical Co., Ltd. — FDA Form 483 Inspection, April 16, 2025 (1 Citations)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-zhejiang-huahai-pharmaceutical-co-ltd-2025-04-16-3003999190},
note = {Accessed: July 13, 2026}
}