3M Company
Form 483 issued November 6, 2015 · Milford, Ohio
- Inspection
- Nov 4 – Nov 6, 2015
- Investigators
- Christina L. Bigham· Teresa K. Kastner
- Observations
- 1
- Pages
- 2
- FEI number
- 1510709
In short: On November 6, 2015, FDA issued a Form 483 with 1 observation to 3M Company in Milford, Ohio (FEI 1510709) after an inspection that ran Nov 4 – Nov 6, 2015. The investigators were Christina L. Bigham and Teresa K. Kastner. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 803.50(a)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted witbin 30 days of receiving or otherwise becoming aware of…
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 firm3M Company history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at 3M Company?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected 3M Company?
Christina L. Bigham and Teresa K. Kastner are named on this Form 483, for the inspection of Nov 4 – Nov 6, 2015. Each investigator has a profile showing what they cite most.
When was 3M Company inspected by FDA?
The inspection ran Nov 4 – Nov 6, 2015, and the Form 483 is dated November 6, 2015.
How do I get the full Form 483 for 3M Company?
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.