3M Company
Form 483 issued September 1, 2015 · Saint Paul, Minnesota
- Inspection
- Aug 25 – Sep 1, 2015
- Investigators
- April L. Young· Patrick B. Cummings
- Observations
- 3
- Pages
- 2
- FEI number
- 3003803251
In short: On September 1, 2015, FDA issued a Form 483 with 3 observations to 3M Company in Saint Paul, Minnesota (FEI 3003803251) after an inspection that ran Aug 25 – Sep 1, 2015. The investigators were April L. Young and Patrick B. Cummings. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Written procedures are not established for evaluations conducted at least annually to review records associated with…
This inspection in context
April L. Young
5 documents · 2014–2015
Cites 211.110 (sampling and testing of in-process materials and drug products) 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 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at 3M Company?
FDA listed 3 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected 3M Company?
April L. Young and Patrick B. Cummings are named on this Form 483, for the inspection of Aug 25 – Sep 1, 2015. Each investigator has a profile showing what they cite most.
When was 3M Company inspected by FDA?
The inspection ran Aug 25 – Sep 1, 2015, and the Form 483 is dated September 1, 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.