AB SCIEX
Form 483 issued January 28, 2016 · Concord, Canada
- Inspection
- Jan 25 – Jan 28, 2016
- Investigator
- Thai Duong
- Observations
- 2
- Pages
- 2
- FEI number
- 3008336863
In short: On January 28, 2016, FDA issued a Form 483 with 2 observations to AB SCIEX in Concord, Ontario Lk v (FEI 3008336863) after an inspection that ran Jan 25 – Jan 28, 2016. The investigator was Thai Duong. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×) · 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Thai Duong
5 documents · 2001–2025
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Utah.
The firmAB SCIEX history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AB SCIEX?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected AB SCIEX?
Thai Duong is named on this Form 483, for the inspection of Jan 25 – Jan 28, 2016. Each investigator has a profile showing what they cite most.
When was AB SCIEX inspected by FDA?
The inspection ran Jan 25 – Jan 28, 2016, and the Form 483 is dated January 28, 2016.
How do I get the full Form 483 for AB SCIEX?
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.