FDA Inspection
Next Life Medical Corp. dba Emergent RespiratoryNext Life Medical Corp. dba Emergent Respiratory – FDA Inspection, Aug 1, 2018
Record Details
This FDA Inspection record concerns Next Life Medical Corp. dba Emergent Respiratory, with an inspection on August 1, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 1, 2018
- Product Type
- Devices
- Person
- Lisa A. Stura (Issuing Officer)
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ID · e60bddf8-0c79-43ff-ad7f-24e6854baeb5
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1061602
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Next Life Medical Corp. dba Emergent Respiratory
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 24, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Next Life Medical Corp. dba Emergent Respiratory
- FDA Inspection 937238 - 2015-07-16
- FDA Inspection 729416 - 2011-05-24
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