Nutrimost, LLC
Form 483 issued March 30, 2016 · Pittsburgh, Pennsylvania
- Inspection
- Feb 5 – Mar 30, 2016
- Investigators
- Carl E. Lovrich· Dennis R. Hock
- Observations
- 1
- Pages
- 1
- FEI number
- 3012205947
In short: On March 30, 2016, FDA issued a Form 483 with 1 observation to Nutrimost, LLC in Pittsburgh, Pennsylvania (FEI 3012205947) after an inspection that ran Feb 5 – Mar 30, 2016. The investigators were Carl E. Lovrich and Dennis R. Hock. The most-cited regulation is 21 CFR 807.81 (when a premarket notification submission is required).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You are currently marketing and distributing the ZYTO Hand Cradle, a medical device, outside the specifications…
This inspection in context
Carl E. Lovrich
1 document · 2016
Cites 807.81 (when a premarket notification submission is required) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmNutrimost, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 807.81
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nutrimost, LLC?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 807.81 (when a premarket notification submission is required). The opening words of each observation are shown on this page.
Who inspected Nutrimost, LLC?
Carl E. Lovrich and Dennis R. Hock are named on this Form 483, for the inspection of Feb 5 – Mar 30, 2016. Each investigator has a profile showing what they cite most.
When was Nutrimost, LLC inspected by FDA?
The inspection ran Feb 5 – Mar 30, 2016, and the Form 483 is dated March 30, 2016.
How do I get the full Form 483 for Nutrimost, LLC?
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.