Zhejiang Huahai Pharmaceutical Co. Ltd.
Form 483 issued January 24, 2025 · Linhai, China
- Inspection
- Jan 16 – Jan 24, 2025
- Investigators
- Jeffrey P. Raimondi· Justin A. Boyd
- Observations
- 7
- Pages
- 11
- FEI number
- 3003999190
In short: On January 24, 2025, FDA issued a Form 483 with 7 observations to Zhejiang Huahai Pharmaceutical Co. Ltd. in Linhai, Zhejiang (FEI 3003999190) after an inspection that ran Jan 16 – Jan 24, 2025. The investigators were Jeffrey P. Raimondi and Justin A. Boyd. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmZhejiang Huahai Pharmaceutical Co. Ltd. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Huahai Pharmaceutical Co. Ltd.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Zhejiang Huahai Pharmaceutical Co. Ltd.?
Jeffrey P. Raimondi and Justin A. Boyd are named on this Form 483, for the inspection of Jan 16 – Jan 24, 2025. Each investigator has a profile showing what they cite most.
When was Zhejiang Huahai Pharmaceutical Co. Ltd. inspected by FDA?
The inspection ran Jan 16 – Jan 24, 2025, and the Form 483 is dated January 24, 2025.
How do I get the full Form 483 for Zhejiang Huahai Pharmaceutical Co. Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.