FDA Inspection
Risingsun Iodine Products Corp.Risingsun Iodine Products Corp. – FDA Inspection, Apr 10, 2009
Record Details
This FDA Inspection record concerns Risingsun Iodine Products Corp., with an inspection on April 10, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 10, 2009
- Product Type
- Drugs
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ID · 5a5ac10a-c79b-4f3b-a557-8f87bb2dce3a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 568098
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
16- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.50Sewage and refuse disposal in safe manner
- 21 CFR 211.82(a)Examination on receipt, before acceptance
- 21 CFR 211.80(d)Identification of Each Lot in Each Shipment
- 21 CFR 211.130(d)Examination of packaging and labeling
- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
Showing 10 of 16 citations.
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Other FDA inspections of Risingsun Iodine Products Corp.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2024 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| April 13, 2022 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 6, 2020 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| November 20, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 16, 2012 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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 767454 - 2012-02-16
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