Company
United StatesAggredyne, Inc., Houston, TX – FDA Inspections
Inspection records and compliance data for Aggredyne, Inc. in Houston, Texas. 3 FDA inspections on record, 1 Form 483, last inspected April 14, 2022.
Company Profile
This profile covers Aggredyne, Inc. based in Houston, Texas, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected April 5, 2016. Last inspected April 14, 2022.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design transfer - Lack of or inadequate procedures1 inspection
- Design validation - software validation not performed1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 14, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1167084 |
| June 5, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1054387 |
| April 5, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 967771 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Aggredyne, Inc.
FEI Number
3009610394
Address
10530 Rockley Rd Ste 150, Houston, Texas 77099, United States
Country
United States
ID: 10ebac9d-35f6-438c-83a7-8d3ab09472a4