FDA Inspection
Innolatex Sdn. Bhd.Innolatex Sdn. Bhd. – FDA Inspection, Jul 27, 2023
Record Details
This FDA Inspection record concerns Innolatex Sdn. Bhd., with an inspection on July 27, 2023, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 7404a2f6-8a69-4b69-8bf4-d269c82a9439
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1215638
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.120(b)Examination for accuracy
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.120(b)Examination for accuracy
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Innolatex Sdn. Bhd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| January 20, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Innolatex Sdn. Bhd.
- FDA Inspection 1009128 - 2017-03-09
- FDA Inspection 752824 - 2011-11-03
- FDA Inspection 709156 - 2011-01-20
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.