FDA Inspection
Athena Feminine Technologies IncorporatedAthena Feminine Technologies Incorporated – FDA Inspection, Aug 8, 2011
Record Details
This FDA Inspection record concerns Athena Feminine Technologies Incorporated, with an inspection on August 8, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 8, 2011
- Product Type
- Devices
View Company Profile
ID · c7799ab6-124d-428f-ba27-40e5f668a267
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 737378
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)Complaints
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.180Availability
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 803.17(b)(2)Reports and information documentation
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