FDA Inspection 999001 — Becton Dickinson and Company
The FDA completed an inspection of Becton Dickinson and Company on January 10, 2017 in Mebane, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 10, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mebane, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |