FDA Inspection
Customer Service Associates, LLCCustomer Service Associates, LLC – FDA Inspection, Oct 21, 2016
Record Details
This FDA Inspection record concerns Customer Service Associates, LLC, with an inspection on October 21, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ff48279a-f675-470b-b9d5-c80cbb0d6df4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 989058
- 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 806.20(b)(4)Justification for not reporting
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Customer Service Associates, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 23, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 16, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Customer Service Associates, LLC
- FDA Inspection 820842 - 2013-02-21
- FDA Inspection 780329 - 2012-04-23
- FDA Inspection 632721 - 2009-09-16
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