Customer Service Associates, LLC
Amended 483 issued October 21, 2016 · Winchester, Tennessee
- Inspection
- Oct 17 – Oct 21, 2016
- Investigator
- Mary A. Millner
- Observations
- 7
- Pages
- 15
- FEI number
- 1037371
In short: On October 21, 2016, FDA issued a Amended 483 with 7 observations to Customer Service Associates, LLC in Winchester, Tennessee (FEI 1037371) after an inspection that ran Oct 17 – Oct 21, 2016. The investigator was Mary A. Millner. Most observations concern cAPA and production & process controls.
At a glance
5 of 7 observations on this amended 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have not…
- 02
Procedures for corrective and preventive action have…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Procedures to control labeling activities have…
3 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Mary A. Millner
9 documents · 2015–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Tennessee.
The firmCustomer Service Associates, LLC history
The site's inspection history, in date order.
Similar documentsOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Customer Service Associates, LLC?
FDA listed 7 observations on this Form 483, mostly about cAPA, production & process controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Customer Service Associates, LLC?
Mary A. Millner is named on this Amended 483, for the inspection of Oct 17 – Oct 21, 2016. Each investigator has a profile showing what they cite most.
When was Customer Service Associates, LLC inspected by FDA?
The inspection ran Oct 17 – Oct 21, 2016, and the Amended 483 is dated October 21, 2016.
How do I get the full Amended 483 for Customer Service Associates, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.