Atlantic Horizon International, Inc
Form 483 issued March 4, 2015 · Beacon, New York
- Inspection
- Feb 25 – Mar 4, 2015
- Investigator
- Jacqueline S. Warner
- Observations
- 7
- Pages
- 4
- FEI number
- 3003598544
In short: On March 4, 2015, FDA issued a Form 483 with 7 observations to Atlantic Horizon International, Inc in Beacon, New York (FEI 3003598544) after an inspection that ran Feb 25 – Mar 4, 2015. The investigator was Jacqueline S. Warner. Most observations concern production & process controls and cAPA.
At a glance
Observations span 4 systems, led by production & process controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for acceptance of incoming product…
- 02
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 04
You did not submit an annual report…
This inspection in context
Jacqueline S. Warner
7 documents · 2008–2024
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in New York.
The firmAtlantic Horizon International, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Atlantic Horizon International, Inc?
FDA listed 7 observations on this Form 483, mostly about production & process controls, cAPA and design controls. The opening words of each observation are shown on this page.
Who inspected Atlantic Horizon International, Inc?
Jacqueline S. Warner is named on this Form 483, for the inspection of Feb 25 – Mar 4, 2015. Each investigator has a profile showing what they cite most.
When was Atlantic Horizon International, Inc inspected by FDA?
The inspection ran Feb 25 – Mar 4, 2015, and the Form 483 is dated March 4, 2015.
How do I get the full Form 483 for Atlantic Horizon International, 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.