Zhejiang Huahai Pharmaceutical Co. Ltd.
Form 483 issued November 18, 2016 · Linhai, China
- Inspection
- Nov 18, 2016
- Investigators
- Justin A. Boyd· Peter E. Baker
- Observations
- 4
- Pages
- 3
- FEI number
- 3003999190
In short: On November 18, 2016, FDA issued a Form 483 with 4 observations to Zhejiang Huahai Pharmaceutical Co. Ltd. in Linhai, Zhejiang (FEI 3003999190) after an inspection that ran Nov 18, 2016. The investigators were Justin A. Boyd and Peter E. Baker. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and…
- 03
Processing areas are deficient regarding the system for cleaning…
- 04
Data is not recorded…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.113
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 4 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Zhejiang Huahai Pharmaceutical Co. Ltd.?
Justin A. Boyd and Peter E. Baker are named on this Form 483, for the inspection of Nov 18, 2016. Each investigator has a profile showing what they cite most.
When was Zhejiang Huahai Pharmaceutical Co. Ltd. inspected by FDA?
The inspection ran Nov 18, 2016, and the Form 483 is dated November 18, 2016.
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.