Company
South AfricaRespitek (Pty) Ltd, Sandton, South Africa – FDA Inspections
Inspection records and compliance data for Respitek (Pty) Ltd in Sandton. 1 FDA inspection on record, last inspected February 11, 2016.
Company Profile
This profile covers Respitek (Pty) Ltd based in Sandton, South Africa.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected February 11, 2016.
Most cited issue areas
- Documentation1 inspection
- Document review, approval by designated individual1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 11, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 958327 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Respitek (Pty) Ltd
FEI Number
3010370451
Address
75 5th Street, Sandton, South Africa
Country
South Africa
ID: ee8afb92-9469-4dfb-8e6b-65c7df544ff5