Zhejiang Bangli Medical Products Co., Ltd. South of YueGui Road 118, Huachuan Block
Form 483 issued August 17, 2016 · Yongkang City, China
- Inspection
- Aug 16 – Aug 17, 2016
- Investigator
- Peter E. Baker
- Observations
- 1
- Pages
- 5
- FEI number
- 3010671506
In short: On August 17, 2016, FDA issued a Form 483 with 1 observation to Zhejiang Bangli Medical Products Co., Ltd. South of YueGui Road 118, Huachuan Block in Yongkang City, China (FEI 3010671506) after an inspection that ran Aug 16 – Aug 17, 2016. The investigator was Peter E. Baker. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no Quality…
This inspection in context
Peter E. Baker
11 documents · 2011–2017
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmZhejiang Bangli Medical Products Co., Ltd. South of YueGui Road 118, Huachuan Block history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Bangli Medical Products Co., Ltd. South of YueGui Road 118, Huachuan Block?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Zhejiang Bangli Medical Products Co., Ltd. South of YueGui Road 118, Huachuan Block?
Peter E. Baker is named on this Form 483, for the inspection of Aug 16 – Aug 17, 2016. Each investigator has a profile showing what they cite most.
When was Zhejiang Bangli Medical Products Co., Ltd. South of YueGui Road 118, Huachuan Block inspected by FDA?
The inspection ran Aug 16 – Aug 17, 2016, and the Form 483 is dated August 17, 2016.
How do I get the full Form 483 for Zhejiang Bangli Medical Products Co., Ltd. South of YueGui Road 118, Huachuan Block?
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.