Company
AustraliaGelflex Laboratories, Malaga, Australia – FDA Inspections
Inspection records and compliance data for Gelflex Laboratories in Malaga. 2 FDA inspections on record, 1 Form 483, last inspected November 30, 2017.
Company Profile
This profile covers Gelflex Laboratories based in Malaga, Australia.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 30, 2015. Last inspected November 30, 2017.
Most cited issue areas
- DHR - not or inadequately maintained1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 30, 2017 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1032353 |
| January 30, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 916761 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Gelflex Laboratories
FEI Number
1000426389
Address
52 Mulgul Rd, Malaga, Australia
Country
Australia
ID: c780b470-5359-47ca-92aa-7530ea259f8c