Nutrishare Inc.
Form 483 issued August 30, 2018 · Louisviiie, Kentucky
- Inspection
- Jul 26, 2018
- Investigator
- Jazmine N. Still
- Observations
- 9
- Pages
- 4
- FEI number
- 3007957196
In short: On August 30, 2018, FDA issued a Form 483 with 9 observations to Nutrishare Inc. in Louisviiie, Kentucky (FEI 3007957196) after an inspection that ran Jul 26, 2018. The investigator was Jazmine N. Still. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 9 of 9 observations.
Most cited: 21 CFR 211.113 (4×) · 211.42 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel conducted aseptic manipulations and placed equipment/supplies in an area that blocked the movement of first…
- 02
ISO 5 classified areas were not…
- 03
The facility design is designed and operated in a way that permits…
- 04
Materials or supplies were not disinfected prior to entering…
This inspection in context
Jazmine N. Still
16 documents · 2017–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmNutrishare Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nutrishare Inc.?
FDA listed 9 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Nutrishare Inc.?
Jazmine N. Still is named on this Form 483, for the inspection of Jul 26, 2018. Each investigator has a profile showing what they cite most.
When was Nutrishare Inc. inspected by FDA?
The inspection ran Jul 26, 2018, and the Form 483 is dated August 30, 2018.
How do I get the full Form 483 for Nutrishare 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.