FDA Inspection 961404 — Waveform Inc
The FDA completed an inspection of Waveform Inc on February 19, 2016 in Marietta, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 19, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Marietta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 3573 | 21 CFR 211.101(b) | Measured components for manufacturing |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4322 | 21 CFR 211.101(d) | Component release checked by 2nd person |
| 4344 | 21 CFR 211.160(b)(1) | Sampling and testing procedures described |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |
| 4410 | 21 CFR 211.194(a)(5) | Calculations performed are in the records |
| 4576 | 21 CFR 211.192 | No written record of investigation |