Mindray DS USA, Inc. dba Mindray North
Form 483 issued March 31, 2016 · Mahwah, New Jersey
- Inspection
- Mar 8 – Mar 31, 2016
- Investigator
- Li Li
- Observations
- 1
- Pages
- 3
- FEI number
- 2221819
In short: On March 31, 2016, FDA issued a Form 483 with 1 observation to Mindray DS USA, Inc. dba Mindray North in Mahwah, New Jersey (FEI 2221819) after an inspection that ran Mar 8 – Mar 31, 2016. The investigator was Li Li. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Complaints involving the possible failure of a device , labeling and packaging to meet any of…
This inspection in context
Li Li
4 documents · 2015–2018
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in New Jersey.
The firmMindray DS USA, Inc. dba Mindray North history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mindray DS USA, Inc. dba Mindray North?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Mindray DS USA, Inc. dba Mindray North?
Li Li is named on this Form 483, for the inspection of Mar 8 – Mar 31, 2016. Each investigator has a profile showing what they cite most.
When was Mindray DS USA, Inc. dba Mindray North inspected by FDA?
The inspection ran Mar 8 – Mar 31, 2016, and the Form 483 is dated March 31, 2016.
How do I get the full Form 483 for Mindray DS USA, Inc. dba Mindray North?
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