FDA Inspection
Myelotec, Inc.Myelotec, Inc. – FDA Inspection, Feb 1, 2017
Record Details
This FDA Inspection record concerns Myelotec, Inc., with an inspection on February 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 460749d6-5c19-4740-8cdd-c83e31dcb2dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1008530
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(g)Design validation - production units
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Myelotec, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Myelotec, Inc.
- FDA Inspection 809094 - 2012-11-14
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.