Company
United StatesRowny Systems, Inc., Cabin John, MD – FDA Inspections
Inspection records and compliance data for Rowny Systems, Inc. in Cabin John, Maryland. 3 FDA inspections on record, 1 Form 483, last inspected June 17, 2022.
Company Profile
This profile covers Rowny Systems, Inc. based in Cabin John, Maryland, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 10, 2014. Last inspected June 17, 2022.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 17, 2022 | VAI | Biologics · Blood and Blood Products | 1172078 |
| September 17, 2019 | VAI | Biologics · Blood and Blood Products | 1102059 |
| February 10, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 866244 |
FDA documents
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Rowny Systems, Inc.
FEI Number
3009768528
Address
6508 81st St, Cabin John, Maryland 20818, United States
Country
United States
ID: 6d971e77-d191-4514-935e-d090f38c9faf