Air Techniques Inc
Form 483 issued April 29, 2016 · Melville, New York
- Inspection
- Apr 12 – Apr 29, 2016
- Investigators
- Dave M. Deroche· Jose O. Hernandez
- Observations
- 4
- Pages
- 5
- FEI number
- 2428225
In short: On April 29, 2016, FDA issued a Form 483 with 4 observations to Air Techniques Inc in Melville, New York (FEI 2428225) after an inspection that ran Apr 12 – Apr 29, 2016. The investigators were Dave M. Deroche and Jose O. Hernandez. Most observations concern production & process controls and records & documents.
At a glance
Production & process controls and records & documents account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Process validation activities and results…
- 02
A device history record has…
- 03
Labels and labeling used for each finished product, lot, or batch, were not sufficiently…
- 04
Complaints involving the possible failure of a device to meet any of its specifications were…
This inspection in context
Dave M. Deroche
2 documents · 2016–2017
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in New Jersey.
The firmAir Techniques Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Air Techniques Inc?
FDA listed 4 observations on this Form 483, mostly about production & process controls, records & documents and cAPA. The opening words of each observation are shown on this page.
Who inspected Air Techniques Inc?
Dave M. Deroche and Jose O. Hernandez are named on this Form 483, for the inspection of Apr 12 – Apr 29, 2016. Each investigator has a profile showing what they cite most.
When was Air Techniques Inc inspected by FDA?
The inspection ran Apr 12 – Apr 29, 2016, and the Form 483 is dated April 29, 2016.
How do I get the full Form 483 for Air Techniques 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.