Company
United KingdomPuretone Ltd., Rochester, United Kingdom – FDA Inspections
Inspection records and compliance data for Puretone Ltd. in Rochester. 1 FDA inspection on record (1 OAI), last inspected November 20, 2008.
Company Profile
This profile covers Puretone Ltd. based in Rochester, United Kingdom.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected November 20, 2008.
Most cited issue areas
- Acceptance records1 inspection
- Design review procedures - personnel1 inspection
- Documentation1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 20, 2008 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 554189 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Puretone Ltd.
FEI Number
3002808722
Address
Unit 9-10, Henley Business Park; Trident Close, Rochester, United Kingdom
Country
United Kingdom
ID: 6539fe49-ce3f-42e4-8c09-0cbbbd5166bd