FDA Inspection 741911 — ABCO Laboratories, Inc.
The FDA completed an inspection of ABCO Laboratories, Inc. on Sep 9, 2011 in Fairfield, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 9, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fairfield, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |