Company
United KingdomOtodynamics Limited, Hatfield, United Kingdom – FDA Inspections
Inspection records and compliance data for Otodynamics Limited in Hatfield. 3 FDA inspections on record, 2 Form 483s, last inspected January 09, 2025.
Company Profile
This profile covers Otodynamics Limited based in Hatfield, United Kingdom.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected February 3, 2017. Last inspected January 9, 2025.
Most cited issue areas
- Evaluation of suppliers, contractors, etc., requirements2 inspections
- Lack of or inadequate procedures2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 9, 2025 | Not classified | Medical Devices & Rad Health | 1261981 |
| September 13, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1065829 |
| February 3, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1003852 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Otodynamics Limited
FEI Number
2939
Address
30-38 Beaconsfield Rd, Hatfield, United Kingdom
Country
United Kingdom
ID: 7928e076-b9e2-4069-be0e-b127e9aa7dd5