FDA Inspection 783684 — Exelead, Inc.
The FDA completed an inspection of Exelead, Inc. on May 11, 2012 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 11, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1933 | 21 CFR 211.167(a) | Sterility/pyrogens - test methods written, followed |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |