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FDA Inspection
•Enterprise Mac, LLC•June 16, 2014

FDA Inspection 884193 - Enterprise Mac, LLC - June 16, 2014

Record Details

This FDA Inspection record concerns Enterprise Mac, LLC, with an inspection on June 16, 2014, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Enterprise Mac, LLC
Inspection Date
June 16, 2014
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · 675e1bc0-83a6-4c93-9366-58a55eb86d95

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
884193
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

12
  1. 21 CFR 111.12(c)Personnel - education, training, experience
  2. 21 CFR 111.80(a)Components packaging, labels received
  3. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  4. 21 CFR 111.70(a)Specifications - manufacturing process
  5. 21 CFR 111.255(d)Batch record - 1 year, 2 years
  6. 21 CFR 111.475(b)(2)Records - product distribution
  7. 21 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
  8. 21 CFR 111.140(b)(1)QC ops; written procedures; material review, disposition
  9. 21 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
  10. 21 CFR 111.205(a)Master manufacturing record - each batch

Showing 10 of 12 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Enterprise Mac, LLC

5
DateClassificationOfficeProject area
April 27, 2026VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
August 4, 2022VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
July 3, 2018VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
November 12, 2015VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
September 3, 2014OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Enterprise Mac, LLC
  • FDA Inspection 1314468 - 2026-04-27
  • FDA Inspection 1176595 - 2022-08-04
  • FDA Inspection 1057760 - 2018-07-03
  • FDA Inspection 951083 - 2015-11-12
  • FDA Inspection 891921 - 2014-09-03

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
info@globalkeysolutions.net
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