Company
United StatesAerscher Diagnostics, LLC, Chestertown, MD – FDA Inspections
Inspection records and compliance data for Aerscher Diagnostics, LLC in Chestertown, Maryland. 4 FDA inspections on record (1 OAI), last inspected June 21, 2024.
Company Profile
This profile covers Aerscher Diagnostics, LLC based in Chestertown, Maryland, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected January 19, 2011. Last inspected June 21, 2024.
Most cited issue areas
- Lack of or inadequate procedures3 inspections
- Lack of or inadequate process validation2 inspections
- Nonconforming product, Lack of or inadequate procedures2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 21, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1241779 |
| June 16, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 973203 |
| February 21, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 768972 |
| January 19, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 705980 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Aerscher Diagnostics, LLC
FEI Number
1000219815
Address
125 Dixon Dr, Chestertown, Maryland 21620, United States
Country
United States
ID: 21faa930-755b-4beb-be2c-f031eb4f9348