FDA Inspection 1028257 — Pharmaceutical Laboratories and Consultants, Inc.
The FDA completed an inspection of Pharmaceutical Laboratories and Consultants, Inc. on October 10, 2017 in Addison, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 10, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Addison, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |