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 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.

November 20, 2024 FDA Form 483 for Zhejiang Huahai Pharmaceutical Co., Ltd.

Key facts

Firm	Zhejiang Huahai Pharmaceutical Co., Ltd.
FEI / inspection ID	3003885745
Inspection end date	November 20, 2024
Citation count	4

The short version: FDA inspected Zhejiang Huahai Pharmaceutical Co., Ltd. in China and issued a Form 483 listing 4 inspectional observations following an inspection that concluded 2024-11-20. FDA records classify Zhejiang Huahai Pharmaceutical Co., Ltd. as a active pharmaceutical ingredient 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.

Citations explained

Observation 1 — Laboratory records do not include complete test data derived from all tests

Laboratory records do not include complete test data derived from all tests. Speci fi cally, A. There is no documentation of raw test data relating to equipment cleaning samples (sw ab and rinse) test solution preparation. For example, Your analytical test procedures for detection of residual active components by UV Spect roscopy and TOC has series of steps such a _______________ (b~or the preparation of cleaning samp les test solution, however your Quality Unit has not establi shed any system in the form of logbook or worksheet for documenting cleani ng test solution preparation. Thereby, your QC Engineers (Analysts) have never documented cleaning test solution preparation pertaining to a ll APls a nd intermediates tested in your QC laboratory. According to your Qualit Assurance Manager, about l.til1l • o of cleaning samples are tested using UV Spectroscopy and about (bT(l 1/o of clean in g samples are tested by TOC method for whi ch there is no documentation relating to.

Observation 2 — Laboratory investigations are not adequately conducted to determine the root cause

Laboratory investigations are not adequately conducted to determine the root cause. Sp ecifica ll y, Y our Out-of-Specification (OOS) investigations fo r equipment clea ni ng samp les (rinse and swab) fai lures does no1 inc lude scienti fic justificat io n suppo rt ed with docume nt ed ev id ence fo r the probab le root cause based on which the DATE ISSUED

Observation 3 — La ck of Quality Unit oversight to ensure integrity o ft est

La ck of Quality Unit oversight to ensure integrity o ft est data and document management. Speci fically, A. On November 14, 2024, we ob se rved (tl1f'l leaning samp les (rinse and swab) mainly relating to product changeover and cleaning validation were pending for testing in your QC laboratory. These equipment DATE ISSUED EMPLOYEE($) SIG NATURE EMP LOY EE($) NAME ANO T IT LE (Print or Typ e) Pratik S. Upadhyay, Invest igator- DOC REti~SE 0_5 uOFTHIS I • 11/20/2024 PAGE la n A. Rivera, Investigator - GOU FA

Observation 4 — The procedure for collecting cleaning samples from the manufactur in g equipment

The procedure for collecting cleaning samples from the manufactur in g equipment is deficient. Specifically, DATE ISSUED

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.

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

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 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.

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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.

APA

Argus HQ Research (2024). November 20, 2024 FDA Form 483 for Zhejiang Huahai Pharmaceutical Co., Ltd. — 4 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-zhejiang-huahai-pharmaceutical-co-ltd-2024-11-20-3003885745

MLA

"November 20, 2024 FDA Form 483 for Zhejiang Huahai Pharmaceutical Co., Ltd. — 4 Citations." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/483/fda-483-zhejiang-huahai-pharmaceutical-co-ltd-2024-11-20-3003885745.

Chicago

Argus HQ Research. "November 20, 2024 FDA Form 483 for Zhejiang Huahai Pharmaceutical Co., Ltd. — 4 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-zhejiang-huahai-pharmaceutical-co-ltd-2024-11-20-3003885745.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_zhejiang_huahai_pharmaceutical_co_ltd_2024_11_20_3003885745_2024,
  title = {November 20, 2024 FDA Form 483 for Zhejiang Huahai Pharmaceutical Co., Ltd. — 4 Citations},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-zhejiang-huahai-pharmaceutical-co-ltd-2024-11-20-3003885745},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗