Warning letter
Becton Dickinson & Company: warning letter of Jan 11, 2018
FDA warning letter 535770 · New England District Office
Key facts
| Reference number | 535770 |
|---|---|
| Company | Becton Dickinson & Company |
| Subject | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Issue date | Jan 11, 2018 |
| Posted date | Jan 11, 2018 |
| Issuing office | New England District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 803.17(a)(1), 803.17(a)(2), 803.50(a)(2), 807.81(a)(3), 820, 803.20(c)(2) |
| Inspection city | Franklin Lakes |
| Inspection ZIP | 07417-1815 |
| Inspection start date | May 15, 2017 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: