Green Sprouts
Form 483 issued August 16, 2023 · Asheville, North Carolina
- Inspection
- Aug 14 – Aug 16, 2023
- Investigator
- Gamal A. Norton
- Observations
- 6
- Pages
- 4
- FEI number
- 3004043909
In short: On August 16, 2023, FDA issued a Form 483 with 6 observations to Green Sprouts in Asheville, North Carolina (FEI 3004043909) after an inspection that ran Aug 14 – Aug 16, 2023. The investigator was Gamal A. Norton. Most observations concern production & process controls and management controls; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
Production & process controls and management controls account for 6 of 6 observations.
Most cited: 21 CFR 820.20(c) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is no agreement with suppliers and contractors to notify you of changes in…
- 02
Procedures to control labeling activities…
- 03
Quality audits have not…
- 04
Management with executive responsibility has not reviewed the suitability and effectiveness…
This inspection in context
Gamal A. Norton
16 documents · 2003–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in North Carolina.
The firmGreen Sprouts history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Green Sprouts?
FDA listed 6 observations on this Form 483, mostly about production & process controls and management controls. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected Green Sprouts?
Gamal A. Norton is named on this Form 483, for the inspection of Aug 14 – Aug 16, 2023. Each investigator has a profile showing what they cite most.
When was Green Sprouts inspected by FDA?
The inspection ran Aug 14 – Aug 16, 2023, and the Form 483 is dated August 16, 2023.
How do I get the full Form 483 for Green Sprouts?
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.