FDA Inspection 1054645 — Jubilant HollisterStier General Partnership
The FDA completed an inspection of Jubilant HollisterStier General Partnership on June 1, 2018 in Kirkland. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 1, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kirkland (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |