FDA Inspection
Del Medical, Inc.Del Medical, Inc. – FDA Inspection, Mar 19, 2021
Record Details
This FDA Inspection record concerns Del Medical, Inc., with an inspection on March 19, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Del Medical, Inc.
- Inspection Date
- March 19, 2021
- Product Type
- Devices
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ID · ceeba5cd-11f6-434b-803f-c4f5e0324eee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1136879
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Del Medical, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 23, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 17, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 16, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Del Medical, Inc.
- FDA Inspection 1059713 - 2018-06-25
- FDA Inspection 943154 - 2015-09-23
- FDA Inspection 810510 - 2012-12-17
- FDA Inspection 652226 - 2010-03-16
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