FDA Inspection 1115290 — Viva Pharmaceutical Inc
The FDA completed an inspection of Viva Pharmaceutical Inc on January 10, 2020 in Richmond. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 10, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Richmond (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2032 | 21 CFR 211.194(b) | Test method modification records not maintained |
| 21297 | 21 CFR 211.186(a) | Master production and control records, procedure |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3636 | 21 CFR 211.170(b)(3) | Retention time for some OTC drugs |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |