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FDA Inspection
•Maine Natural Health, Inc.•May 3, 2017

Maine Natural Health, Inc. – FDA Inspection, May 3, 2017

Record Details

This FDA Inspection record concerns Maine Natural Health, Inc., with an inspection on May 3, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Maine Natural Health, Inc.
Inspection Date
May 3, 2017
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
Person
  • Gerard D. Difiore (Issuing Officer)
View Company Profile

ID · 19338edc-f5ef-424c-af13-0cf0f181a894

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1010614
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ
Outcome
Form 483 issued

FDA Citations

8
  1. 21 CFR 111.27(d)(6)Cleaning compounds - adequate, safe
  2. 21 CFR 111.15(k)Sanitation supervisors - assigned
  3. 21 CFR 111.80(c)Specifications - representative samples; finished batch
  4. 21 CFR 111.205(a)Master manufacturing record - each batch
  5. 21 CFR 111.75(c)(3)Specifications met identity,purity, strength, comp,; basis
  6. 21 CFR 111.15(i)Hand-washing facilities
  7. 21 CFR 111.210(f)Master manufacturing record theoretical and expected yield
  8. 21 CFR 111.77(a)Specifications not met - reject, quality control

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Maine Natural Health, Inc.

3
DateClassificationOfficeProject area
January 16, 2019VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
February 9, 2015VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
August 29, 2012VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Maine Natural Health, Inc.
  • FDA Inspection 1077029 - 2019-01-16
  • FDA Inspection 916286 - 2015-02-09
  • FDA Inspection 797251 - 2012-08-29

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