Company
United StatesKEOS LLC, Lancaster, PA – FDA Inspections
Inspection records and compliance data for KEOS LLC in Lancaster, Pennsylvania. 2 FDA inspections on record, 1 Form 483, last inspected January 11, 2023.
Company Profile
This profile covers KEOS LLC based in Lancaster, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 23, 2019. Last inspected January 11, 2023.
Most cited issue areas
- Design input - Lack of or inadequate procedures1 inspection
- Design review - Lack of or inadequate procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 11, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1196580 |
| August 23, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1100408 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
KEOS LLC
FEI Number
3013921069
Address
1824 Colonial Village Ln, Lancaster, Pennsylvania 17601, United States
Country
United States
ID: 46e19ba4-a420-4ecf-a317-0e59efaefa22