FDA Inspection
Medical Components SpecialistsMedical Components Specialists – FDA Inspection, May 7, 2019
Record Details
This FDA Inspection record concerns Medical Components Specialists, with an inspection on May 7, 2019, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · cf16b7fa-11be-43f5-9c3f-0ababbe7d56d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1088808
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.90(a)Nonconforming product control
Full citation text and observation details available on the Dashboard.
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.