Company
United StatesXtreem Pulse LLC, New York, NY – FDA Inspections
Inspection records and compliance data for Xtreem Pulse LLC in New York, New York. 3 FDA inspections on record, 2 Form 483s, last inspected October 13, 2023.
Company Profile
This profile covers Xtreem Pulse LLC based in New York, New York, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected June 19, 2019. Last inspected October 13, 2023.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design history file1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 13, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1220381 |
| June 29, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1173093 |
| June 19, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1094170 |
FDA documents
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Xtreem Pulse LLC
FEI Number
3012470925
Address
353 W 29th St Apt 3, New York, New York 10001, United States
Country
United States
ID: 4369da2f-f49e-455a-97cd-8b3efa71f387