Nutri-Dyn Midwest, Inc
Form 483 issued April 10, 2015 · Maple Plain, Minnesota
- Inspection
- Mar 24 – Apr 10, 2015
- Investigators
- Edward M. James· Lauren E. Sanger
- Observations
- 4
- Pages
- 3
- FEI number
- 2126636
In short: On April 10, 2015, FDA issued a Form 483 with 4 observations to Nutri-Dyn Midwest, Inc in Maple Plain, Minnesota (FEI 2126636) after an inspection that ran Mar 24 – Apr 10, 2015. The investigators were Edward M. James and Lauren E. Sanger. Most observations concern dietary supplement CGMP.
At a glance
3 of 4 observations on this 483 concern dietary supplement cgmp.
What FDA observed
Preview: the opening words of each observation- 01FDCA 761(b)(1)
No report was made of a serious adverse event associated with a dietary supplement marketed…
- 02
You did not establish product specifications for the identity, purity, strength, and composition of…
- 03
Your quality control personnel did not reject a dietaiy supplement for which a…
- 04
A qualified person did not review a product complaint to determine whether the product complaint involves…
This inspection in context
Edward M. James
1 document · 2015
Cites 111.560(a)(1) (what requirements apply to the review and investigation of a product complaint?) more than any other section. Most of their documents are for sites in Minnesota.
The firmNutri-Dyn Midwest, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 111.70(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nutri-Dyn Midwest, Inc?
FDA listed 4 observations on this Form 483, mostly about dietary supplement CGMP. The opening words of each observation are shown on this page.
Who inspected Nutri-Dyn Midwest, Inc?
Edward M. James and Lauren E. Sanger are named on this Form 483, for the inspection of Mar 24 – Apr 10, 2015. Each investigator has a profile showing what they cite most.
When was Nutri-Dyn Midwest, Inc inspected by FDA?
The inspection ran Mar 24 – Apr 10, 2015, and the Form 483 is dated April 10, 2015.
How do I get the full Form 483 for Nutri-Dyn Midwest, 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.