Abbott Point of Care Canada Limited
FDA warning letter issued 2022-11-08 · posted 2023-04-19
Letter details
- Company
- Abbott Point of Care Canada Limited
- Subject
- Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
- Issuing office
- Center for Devices and Radiological Health
- Letter issue date
- 2022-11-08
- Posted date
- 2023-04-19
- Case number
- 640946
Read the full letter on fda.gov
FDA's public listing keeps roughly five years of letters; older ones roll off. Atlas preserves every letter it has ingested since September 2026 and refreshes the listing weekly. Verify enforcement matters against the primary source linked above.
Hear about the next one
Watch an issuing office from its directory page and new letters land in your change alerts. Elsewhere this data sells for hundreds of dollars per document; here it is part of the record.