Arrow International Inc
Form 483 issued June 20, 2016 · Reading, Pennsylvania
- Inspection
- Jun 9 – Jun 20, 2016
- Investigators
- Brian S. Keefer· Jacob M. Dyer
- Observations
- 1
- Pages
- 2
- FEI number
- 2518433
In short: On June 20, 2016, FDA issued a Form 483 with 1 observation to Arrow International Inc in Reading, Pennsylvania (FEI 2518433) after an inspection that ran Jun 9 – Jun 20, 2016. The investigators were Brian S. Keefer and Jacob M. Dyer. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.70 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Production processes were not conducted to ensure that a device…
This inspection in context
Brian S. Keefer
6 documents · 2011–2019
Cites 118.10(a)(3)(iv) (recordkeeping requirements for the salmonella enteritidis (se) prevention plan) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmArrow International Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.70
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Arrow International Inc?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Arrow International Inc?
Brian S. Keefer and Jacob M. Dyer are named on this Form 483, for the inspection of Jun 9 – Jun 20, 2016. Each investigator has a profile showing what they cite most.
When was Arrow International Inc inspected by FDA?
The inspection ran Jun 9 – Jun 20, 2016, and the Form 483 is dated June 20, 2016.
How do I get the full Form 483 for Arrow 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.