FDA Inspection 1094205 — Jazz Pharmaceuticals, Inc
The FDA completed an inspection of Jazz Pharmaceuticals, Inc on June 10, 2019 in Palo Alto, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 10, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Palo Alto, CA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 21355 | FDCA 505-1(f)(3)(B) | Failure to comply with REMS Elements to Assure Safe Use (ETASU) B |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6842 | 21 CFR 314.80(j) | Failure to maintain records |