Select Corporation
Form 483 issued January 20, 2017 · Carrollton, Texas
- Inspection
- Jan 17 – Jan 20, 2017
- Investigator
- Shawn E. Larson
- Observations
- 3
- Pages
- 2
- FEI number
- 3003727136
In short: On January 20, 2017, FDA issued a Form 483 with 3 observations to Select Corporation in Carrollton, Texas (FEI 3003727136) after an inspection that ran Jan 17 – Jan 20, 2017. The investigator was Shawn E. Larson. Most observations concern quality system and packaging & labeling.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
The procedures for the annual quality standards record evaluation are deficient in that they do not…
- 02
There is a lack of written procedures describing in sufficient detail the handling, sampling and examination…
- 03
Written procedures describing the handling of all written and oral complaints do not include provisions for…
This inspection in context
Shawn E. Larson
8 documents · 2015–2020
Cites 211.160(a) (general requirements) more than any other section. Most of their documents are for sites in Texas.
The firmSelect Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.180(e)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Select Corporation?
FDA listed 3 observations on this Form 483, mostly about quality system and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Select Corporation?
Shawn E. Larson is named on this Form 483, for the inspection of Jan 17 – Jan 20, 2017. Each investigator has a profile showing what they cite most.
When was Select Corporation inspected by FDA?
The inspection ran Jan 17 – Jan 20, 2017, and the Form 483 is dated January 20, 2017.
How do I get the full Form 483 for Select Corporation?
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.