ALR Technologies
Form 483 issued March 22, 2016 · North Chesterfield, Virginia
- Inspection
- Mar 7 – Mar 22, 2016
- Investigators
- Joey C. West· Tiki Dixon
- Observations
- 13
- Pages
- 11
- FEI number
- 3009349614
In short: On March 22, 2016, FDA issued a Form 483 with 13 observations to ALR Technologies in North Chesterfield, Virginia (FEI 3009349614) after an inspection that ran Mar 7 – Mar 22, 2016. The investigators were Joey C. West and Tiki Dixon. Most observations concern management controls and production & process controls; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
Management controls and production & process controls account for 8 of 13 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for management review have…
- 02
Personnel do not have the necessary education , training and experience…
- 03
Procedures for quality audits have…
- 04
Procedures for identifying product during all stages of receipt, production, distribution, and installation have…
This inspection in context
Joey C. West
8 documents · 2009–2019
Cites 118.10 (recordkeeping requirements for the salmonella enteritidis (se) prevention plan) more than any other section. Most of their documents are for sites in Virginia.
The firmALR Technologies history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ALR Technologies?
FDA listed 13 observations on this Form 483, mostly about management controls, production & process controls and records & documents. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected ALR Technologies?
Joey C. West and Tiki Dixon are named on this Form 483, for the inspection of Mar 7 – Mar 22, 2016. Each investigator has a profile showing what they cite most.
When was ALR Technologies inspected by FDA?
The inspection ran Mar 7 – Mar 22, 2016, and the Form 483 is dated March 22, 2016.
How do I get the full Form 483 for ALR Technologies?
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.