Company
United StatesRESTECH, dba Mederi RF LLC, Houston, TX – FDA Inspections
Inspection records and compliance data for RESTECH, dba Mederi RF LLC in Houston, Texas. 1 FDA inspection on record, 1 Form 483, last inspected September 18, 2024.
Company Profile
This profile covers RESTECH, dba Mederi RF LLC based in Houston, Texas, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected September 18, 2024.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation - software validation not performed1 inspection
- Incorrect translation to production specifications1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 18, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1249477 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
RESTECH, dba Mederi RF LLC
FEI Number
3014545051
Address
11011 Brooklet Dr Ste 300, Houston, Texas 77099, United States
Country
United States
ID: 2bfe885a-9927-4ae0-a1e3-7fd3efd9e220