Hangzhou Linkeweier Daily Chemicals Co. Ltd
Form 483 issued September 17, 2019 · Hangzhou, China
- Inspection
- Sep 11 – Sep 17, 2019
- Investigator
- Sony Laurimer
- Observations
- 1
- Pages
- 10
- FEI number
- 3014324616
In short: On September 17, 2019, FDA issued a Form 483 with 1 observation to Hangzhou Linkeweier Daily Chemicals Co. Ltd in Hangzhou, China (FEI 3014324616) after an inspection that ran Sep 11 – Sep 17, 2019. The investigator was Sony Laurimer. 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
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Sony Laurimer
1 document · 2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in China.
The firmHangzhou Linkeweier Daily Chemicals Co. Ltd history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Hangzhou Linkeweier Daily Chemicals Co. Ltd?
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 Hangzhou Linkeweier Daily Chemicals Co. Ltd?
Sony Laurimer is named on this Form 483, for the inspection of Sep 11 – Sep 17, 2019. Each investigator has a profile showing what they cite most.
When was Hangzhou Linkeweier Daily Chemicals Co. Ltd inspected by FDA?
The inspection ran Sep 11 – Sep 17, 2019, and the Form 483 is dated September 17, 2019.
How do I get the full Form 483 for Hangzhou Linkeweier Daily Chemicals 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.