FDA Inspection
Starkey Laboratories, Inc - Brownsville Distribution CenterStarkey Laboratories, Inc - Brownsville Distribution Center – FDA Inspection, Nov 20, 2013
Record Details
This FDA Inspection record concerns Starkey Laboratories, Inc - Brownsville Distribution Center, with an inspection on November 20, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 20, 2013
- Product Type
- Devices
View Company Profile
ID · 9edcdcff-5697-473f-adf9-d20ddcc0b227
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857282
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Starkey Laboratories, Inc - Brownsville Distribution Center
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2024 | Not classified | Dallas District Office | |
| August 17, 2018 | Not classified | Dallas District Office |
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