FDA Inspection 568098 — Risingsun Iodine Products Corp.
The FDA completed an inspection of Risingsun Iodine Products Corp. on April 10, 2009 in Livingston, MT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 10, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Livingston, MT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1796 | 21 CFR 211.80(d) | Identification of Each Lot in Each Shipment |
| 1797 | 21 CFR 211.82(a) | Examination on receipt, before acceptance |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 3556 | 21 CFR 211.50 | Sewage and refuse disposal in safe manner |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4343 | 21 CFR 211.160(b)(1) | Incoming lots - conformance to written specs- |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |