FDA Inspection
Innolatex Sdn. Bhd.Innolatex Sdn. Bhd. – FDA Inspection, Jan 20, 2011
Record Details
This FDA Inspection record concerns Innolatex Sdn. Bhd., with an inspection on January 20, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Innolatex Sdn. Bhd.
- Inspection Date
- January 20, 2011
- Product Type
- Devices
View Company Profile
ID · a810433c-b08b-44c3-89a5-e10705837ce8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 709156
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Innolatex Sdn. Bhd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 9, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 3, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Innolatex Sdn. Bhd.
- FDA Inspection 1215638 - 2023-07-27
- FDA Inspection 1009128 - 2017-03-09
- FDA Inspection 752824 - 2011-11-03
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.