FDA Inspection 779095 — Tarmac Products, Inc.
The FDA completed an inspection of Tarmac Products, Inc. on May 2, 2012 in Miami Gardens, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 2, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami Gardens, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |