FDA Inspection
Sirtex Singapore Manufacturing Pte LtdSirtex Singapore Manufacturing Pte Ltd – FDA Inspection, Aug 15, 2013
Record Details
This FDA Inspection record concerns Sirtex Singapore Manufacturing Pte Ltd, with an inspection on August 15, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 15, 2013
- Product Type
- Devices
View Company Profile
ID · 636e4362-be16-4d2f-84b1-b4560946361f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 845597
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sirtex Singapore Manufacturing Pte Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 3, 2018 | Not classified | Office of Inspections and Investigations | |
| May 31, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sirtex Singapore Manufacturing Pte Ltd
- FDA Inspection 1122618 - 2018-10-03
- FDA Inspection 786426 - 2012-05-31
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.