Company
South AfricaGlycar SA Pty., Ltd., Irene, South Africa – FDA Inspections
Inspection records and compliance data for Glycar SA Pty., Ltd. in Irene. 1 FDA inspection on record, 1 Form 483, last inspected August 10, 2017.
Company Profile
This profile covers Glycar SA Pty., Ltd. based in Irene, South Africa.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected August 10, 2017.
Most cited issue areas
- Equipment suitability & capability1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 10, 2017 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1021054 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Glycar SA Pty., Ltd.
FEI Number
3002807088
Address
1 Albert Road, box 967, Irene, South Africa
Country
South Africa
ID: 6e1aa17b-0445-421c-9f6a-793cc78cd9a7