FDA Inspection
EPTAM West, LLC. dba EPTAM Rapid Launch CenterEPTAM West, LLC. dba EPTAM Rapid Launch Center – FDA Inspection, Oct 16, 2014
Record Details
This FDA Inspection record concerns EPTAM West, LLC. dba EPTAM Rapid Launch Center, with an inspection on October 16, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 16, 2014
- Product Type
- Devices
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ID · a14fc9cc-3243-4b9b-bb4c-c5e7f42e7528
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 900227
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of EPTAM West, LLC. dba EPTAM Rapid Launch Center
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 26, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for EPTAM West, LLC. dba EPTAM Rapid Launch Center
- FDA Inspection 1195900 - 2023-01-24
- FDA Inspection 985364 - 2016-08-26
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