Company
United StatesApneicare LLC dba Patient Safety Inc., Columbus, OH – FDA Inspections
Inspection records and compliance data for Apneicare LLC dba Patient Safety Inc. in Columbus, Ohio. 5 FDA inspections on record, 1 Form 483, last inspected April 12, 2024.
Company Profile
This profile covers Apneicare LLC dba Patient Safety Inc. based in Columbus, Ohio, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 18, 2011. Last inspected April 12, 2024.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design input - Lack of or inadequate procedures1 inspection
- Design output - Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 12, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1236625 |
| August 23, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1178056 |
| July 26, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1019443 |
| May 5, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 924046 |
| February 18, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 710837 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Apneicare LLC dba Patient Safety Inc.
FEI Number
3007799743
Address
985 Schrock Rd, Columbus, Ohio 43229, United States
Country
United States
ID: dcf788e6-0728-42cc-b0ae-59b5ddc51343