FDA Inspection 1179756 — Partner Therapeutics, Inc.
The FDA completed an inspection of Partner Therapeutics, Inc. on Sep 16, 2022 in Lexington, MA. 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)
- End Date
- Sep 16, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Lexington, MA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 9095 | 21 CFR 600.80(c)(1)(i) | Reporting Requirements - 15-day alert |
| 9096 | 21 CFR 600.80(c)(1)(ii) | Reporting Requirements - 15-day alert follow up |