American Performance Polymers, LLC
Form 483 issued December 21, 2022 · Colebrook, New Hampshire
- Inspection
- Nov 29 – Dec 21, 2022
- Investigator
- Eric C. Schmitt
- Observations
- 6
- Pages
- 6
- FEI number
- 3015909521
In short: On December 21, 2022, FDA issued a Form 483 with 6 observations to American Performance Polymers, LLC in Colebrook, New Hampshire (FEI 3015909521) after an inspection that ran Nov 29 – Dec 21, 2022. The investigator was Eric C. Schmitt. Most observations concern records & documents and cAPA.
At a glance
Records & documents and capa account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
A device master record…
- 02
Procedures for device history records…
- 03
Collective and preventive action activities and/or results have…
- 04
Complaint files are not…
This inspection in context
Eric C. Schmitt
3 documents · 2022–2026
Cites 820.100(b) (corrective and preventive action) more than any other section. Most of their documents are for sites in Connecticut.
The firmAmerican Performance Polymers, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.181
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Performance Polymers, LLC?
FDA listed 6 observations on this Form 483, mostly about records & documents, cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected American Performance Polymers, LLC?
Eric C. Schmitt is named on this Form 483, for the inspection of Nov 29 – Dec 21, 2022. Each investigator has a profile showing what they cite most.
When was American Performance Polymers, LLC inspected by FDA?
The inspection ran Nov 29 – Dec 21, 2022, and the Form 483 is dated December 21, 2022.
How do I get the full Form 483 for American Performance Polymers, 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.