FDA Inspection 903900 — ABCO Laboratories, Inc.
The FDA completed an inspection of ABCO Laboratories, Inc. on November 4, 2014 in Fairfield, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 4, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fairfield, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1449 | 21 CFR 211.111 | Deviations of production time limits |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |