FDA Inspection
Medical Components, Inc dba MedCompMedical Components, Inc dba MedComp – FDA Inspection, Nov 9, 2009
Record Details
This FDA Inspection record concerns Medical Components, Inc dba MedComp, with an inspection on November 9, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 9, 2009
- Product Type
- Drugs
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ID · 30124c7b-96bf-4b7b-817f-e903700c8e1d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 629432
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 820.198(a)General
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 211.115(a)Reprocessing procedures lack steps to be taken
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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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 |
| June 14, 2017 | VAI | 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 |
Other documents for Medical Components, Inc dba MedComp
- FDA Inspection 1155357 - 2021-09-23
- FDA Inspection 1014083 - 2017-06-14
- FDA Inspection 940916 - 2015-09-10
- FDA Inspection 916007 - 2015-02-12
- FDA Inspection 774963 - 2012-03-19
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