Company
United StatesTDM Surgitech, Inc., Palm Harbor, FL – FDA Inspections
Inspection records and compliance data for TDM Surgitech, Inc. in Palm Harbor, Florida. 1 FDA inspection on record, 1 Form 483, last inspected November 28, 2017.
Company Profile
This profile covers TDM Surgitech, Inc. based in Palm Harbor, Florida, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected November 28, 2017.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design review - Lack of or inadequate procedures1 inspection
- Design validation - production units1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 28, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1033871 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
TDM Surgitech, Inc.
FEI Number
3011680080
Address
3667 Arbor Chase Dr, Palm Harbor, Florida 34683, United States
Country
United States
ID: 60b6aecb-7a02-4ba0-a178-1dee357b12c3