FDA Inspection
Medical Components, Inc dba MedCompMedical Components, Inc dba MedComp – FDA Inspection, Jun 14, 2017
Record Details
This FDA Inspection record concerns Medical Components, Inc dba MedComp, with an inspection on June 14, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · b68461df-ccd1-4e83-bf53-69398e5690ff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014083
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)(1)Documented evaluation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medical Components, Inc dba MedComp
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 10, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 12, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 19, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 9, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Medical Components, Inc dba MedComp
- FDA Inspection 1155357 - 2021-09-23
- FDA Inspection 940916 - 2015-09-10
- FDA Inspection 916007 - 2015-02-12
- FDA Inspection 774963 - 2012-03-19
- FDA Inspection 629432 - 2009-11-09
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.