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FDA Inspection
•Sterling USA Nutraceuticals Lab, LLC•May 21, 2012

Sterling USA Nutraceuticals Lab, LLC – FDA Inspection, May 21, 2012

Record Details

This FDA Inspection record concerns Sterling USA Nutraceuticals Lab, LLC, with an inspection on May 21, 2012, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Sterling USA Nutraceuticals Lab, LLC
Inspection Date
May 21, 2012
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · b1990385-4028-480b-b08d-d30ce826c1dc

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
782308
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

12
  1. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  2. 21 CFR 111.65Quality control - quality, dietary supplement
  3. 21 CFR 111.35(b)(3)Documentation - instruments, controls; calibrations
  4. 21 CFR 111.35(b)(2)Document-equipment date of use, maintain, clean, sanitize
  5. 21 CFR 111.14(b)(2)Personnel - records - training
  6. 21 CFR 111.35(b)(1)(ii)Procedures - equipment; calibrating, inspecting, checking
  7. 21 CFR 111.35(b)(1)(iii)Procedures contact surfaces; maintaining, cleaning, sanitize
  8. 21 CFR 111.255(a)Batch record - every batch
  9. 21 CFR 111.205(a)Master manufacturing record - unique formulation
  10. 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier

Showing 10 of 12 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Sterling USA Nutraceuticals Lab, LLC

3
DateClassificationOfficeProject area
July 13, 2022VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
August 12, 2016VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
June 11, 2013VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Sterling USA Nutraceuticals Lab, LLC
  • FDA Inspection 1174919 - 2022-07-13
  • FDA Inspection 983071 - 2016-08-12
  • FDA Inspection 836556 - 2013-06-11

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