FDA Intel

Mindray DS USA, Inc. dba Mindray North

FDA inspection history in Mahwah, New Jersey, 2012 to 2016

1
Form 483
1
Warning letter

Every document, by year

  • Form 483
  • Warning letter

2012: one warning letter; 2016: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2012One warning letter, at Mahwah, New Jersey.
  2. 2016One Form 483, at Mahwah, New Jersey.

Cited most

Across all Mindray DS USA, Inc. dba Mindray North observations on file

The complete Mindray DS USA, Inc. dba Mindray North file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Documents

2 on file, newest first
DateDocumentPrice
2016-03-31483 Form 483$99
2012-11-29Warning letter Warning letter$99

Investigators on these documents

Li Li (1)

FEI number 2221819 · most recent document Mar 31, 2016

About Mindray DS USA, Inc. dba Mindray North

How many FDA Form 483s has Mindray DS USA, Inc. dba Mindray North received?

FDA Intel has 1 Form 483 on file for Mindray DS USA, Inc. dba Mindray North; the most recent is dated Mar 31, 2016.

When was Mindray DS USA, Inc. dba Mindray North last inspected by FDA?

The most recent FDA inspection document on file for Mindray DS USA, Inc. dba Mindray North is a Form 483 dated Mar 31, 2016, for the site in Mahwah, New Jersey.

What did FDA cite at Mindray DS USA, Inc. dba Mindray North?

The regulations cited most in the observations on file for Mindray DS USA, Inc. dba Mindray North are 21 CFR 820.198(c) (Complaint files), 1 time.

Has Mindray DS USA, Inc. dba Mindray North received an FDA warning letter?

Yes. FDA Intel has 1 FDA warning letter on file for Mindray DS USA, Inc. dba Mindray North; the most recent is dated Nov 29, 2012.