Customer Service Associates, LLC
FDA inspection history in Winchester, Tennessee, 2016
- 1
- Form 483
Every document, by year
- Form 483
2016: one amended 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One amended 483, at Winchester, Tennessee.
Cited most
Across all Customer Service Associates observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 806.20(b)(4)Records of corrections and removals not required to be reported1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.120Device labeling1
- 21 CFR 820.184Device history record1
The complete Customer Service Associates file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Winchester, Tennessee
One amended 483 · 2016 · 7 observations
Latest: Form 483, Oct 21, 2016 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-10-21 | Amended 483 Amended 483 | Winchester, Tennessee | 7 | $99 |
Investigators on these documents
FEI number 1037371 · most recent document Oct 21, 2016
About Customer Service Associates, LLC
How many FDA Form 483s has Customer Service Associates, LLC received?
FDA Intel has 1 Form 483 on file for Customer Service Associates, LLC; the most recent is dated Oct 21, 2016.
When was Customer Service Associates, LLC last inspected by FDA?
The most recent FDA inspection document on file for Customer Service Associates, LLC is a Form 483 dated Oct 21, 2016, for the site in Winchester, Tennessee.
What did FDA cite at Customer Service Associates, LLC?
The regulations cited most in the observations on file for Customer Service Associates, LLC are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 806.20(b)(4) (Records of corrections and removals not required to be reported), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.