Company
United StatesArteriocyte Medical Systems Inc, Hopkinton, MA – FDA Inspections
Inspection records and compliance data for Arteriocyte Medical Systems Inc in Hopkinton, Massachusetts. 6 FDA inspections on record, last inspected November 15, 2019.
Company Profile
This profile covers Arteriocyte Medical Systems Inc based in Hopkinton, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected July 10, 2009. Last inspected November 15, 2019.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
- Procedures not adequately established or maintained1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 15, 2019 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1113436 |
| May 24, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1057303 |
| October 1, 2015 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 946533 |
| December 11, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 810191 |
| January 25, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 640530 |
| July 10, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 597067 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Arteriocyte Medical Systems Inc
FEI Number
3006788678
Address
45 South St, Hopkinton, Massachusetts 01748, United States
Country
United States
ID: 6dc51eb6-3962-4493-ac18-c09c6ef6a4de