FDA Inspection 655997 — IodiTech, Inc.
The FDA completed an inspection of IodiTech, Inc. on April 2, 2010 in Kansas City, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 2, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kansas City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4348 | 21 CFR 211.160(b)(2) | In-process materials - sampling, testing procedures |