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FDA Inspection
•Risingsun Iodine Products Corp.•February 16, 2012

Risingsun Iodine Products Corp. – FDA Inspection, Feb 16, 2012

Record Details

This FDA Inspection record concerns Risingsun Iodine Products Corp., with an inspection on February 16, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Risingsun Iodine Products Corp.
Inspection Date
February 16, 2012
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 802b3cc3-bd58-423c-9b3c-06605ebb5875

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
767454
FDA center
Human Drugs
Project area
Unapproved and Misbranded Drugs

FDA Citations

12
  1. Procedural requirements
  2. 21 CFR 111.83(a)Reserve sample - collect, hold
  3. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  4. 21 CFR 111.70(b)(1)Specifications - component identity
  5. 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
  6. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  7. 21 CFR 111.610(a)Records - available; FDA
  8. 21 CFR 111.55Production, process controls - implement
  9. 21 CFR 111.180(b)(3)Documentation - components
  10. 21 CFR 111.535(b)(2)Records - ret"nd dietary supplement: material review, dispos

Showing 10 of 12 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Risingsun Iodine Products Corp.

6
DateClassificationOfficeProject area
August 29, 2024VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
April 13, 2022NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
August 6, 2020NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
November 20, 2019VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
December 14, 2010VAICenter for Drug Evaluation and ResearchUnapproved and Misbranded Drugs
View all 6 other inspections on the company page
Other documents for Risingsun Iodine Products Corp.
  • FDA Inspection 1238943 - 2024-08-29
  • FDA Inspection 1171033 - 2022-04-13
  • FDA Inspection 1127414 - 2020-08-06
  • FDA Inspection 1114120 - 2019-11-20
  • FDA Inspection 701865 - 2010-12-14

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