FDA Inspection
ApelemApelem – FDA Inspection, Jan 26, 2017
Record Details
This FDA Inspection record concerns Apelem, with an inspection on January 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 60171ec2-1ae8-4dd8-8d15-c48029bdb86d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002222
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(d)Service reports
- 21 CFR 820.170(b)Installer records
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Other FDA inspections of Apelem
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 25, 2019 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Apelem
- FDA Inspection 1194056 - 2022-12-08
- FDA Inspection 1082641 - 2019-01-25
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