Crest Electronics Inc
Form 483 issued December 28, 2022 · Dassel, Minnesota
- Inspection
- Dec 6 – Dec 28, 2022
- Investigator
- Christina L. Bigham
- Observations
- 5
- Pages
- 5
- FEI number
- 3002713667
In short: On December 28, 2022, FDA issued a Form 483 with 5 observations to Crest Electronics Inc in Dassel, Minnesota (FEI 3002713667) after an inspection that ran Dec 6 – Dec 28, 2022. The investigator was Christina L. Bigham. Most observations concern production & process controls and design controls.
At a glance
3 of 5 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design change have…
- 02
Procedures that define the responsibility for review and the authority for the disposition of nonconforming product…
- 03
Procediues for acceptance of incoming product have…
- 04
Procediues to ensure sampling methods are adequate for then- intended use have…
This inspection in context
Christina L. Bigham
11 documents · 2015–2026
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Minnesota.
The firmCrest Electronics Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Crest Electronics Inc?
FDA listed 5 observations on this Form 483, mostly about production & process controls, design controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Crest Electronics Inc?
Christina L. Bigham is named on this Form 483, for the inspection of Dec 6 – Dec 28, 2022. Each investigator has a profile showing what they cite most.
When was Crest Electronics Inc inspected by FDA?
The inspection ran Dec 6 – Dec 28, 2022, and the Form 483 is dated December 28, 2022.
How do I get the full Form 483 for Crest Electronics 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.