FDA Inspection 1169285 — Pharmacyclics LLC
The FDA completed an inspection of Pharmacyclics LLC on Apr 27, 2022 in South San Francisco, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 27, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- South San Francisco, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7452 | 21 CFR 312.56(c) | IND safety report |
| 7507 | 21 CFR 312.52(a) | Transfer of obligations |