FDA Inspection 594557 — Exelead, Inc.
The FDA completed an inspection of Exelead, Inc. on Jun 17, 2009 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 17, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |