Draeger Medical Systems, Inc
Form 483 issued September 20, 2019 · Andover, Massachusetts
- Inspection
- Sep 20, 2019
- Investigators
- Justine M. Corson· Matthew B. Hazelett
- Observations
- 1
- Pages
- 9
- FEI number
- 3005783425
In short: On September 20, 2019, FDA issued a Form 483 with 1 observation to Draeger Medical Systems, Inc in Andover, Massachusetts (FEI 3005783425) after an inspection that ran Sep 20, 2019. The investigators were Justine M. Corson and Matthew B. Hazelett. The most-cited regulation is 21 CFR 807.81 (when a premarket notification submission is required).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Premarket notification was not submitted to FDA at least 90 days before the introduction into interstate…
This inspection in context
Justine M. Corson
5 documents · 2012–2019
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmDraeger Medical Systems, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 807.81
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Draeger Medical Systems, Inc?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 807.81 (when a premarket notification submission is required). The opening words of each observation are shown on this page.
Who inspected Draeger Medical Systems, Inc?
Justine M. Corson and Matthew B. Hazelett are named on this Form 483, for the inspection of Sep 20, 2019. Each investigator has a profile showing what they cite most.
When was Draeger Medical Systems, Inc inspected by FDA?
The inspection ran Sep 20, 2019, and the Form 483 is dated September 20, 2019.
How do I get the full Form 483 for Draeger Medical Systems, Inc?
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.