Duralife-USA, LLC
FDA inspection history in South Williamsport, Pennsylvania, 2017
- 1
- Form 483
Every document, by year
- Form 483
2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at South Williamsport, Pennsylvania.
Cited most
Across all Duralife-USA 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 820.198Complaint files1
- 21 CFR 820.20Management responsibility1
The complete Duralife-USA file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
South Williamsport, Pennsylvania
One Form 483 · 2017 · 3 observations
Latest: Form 483, Feb 7, 2017 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-02-07 | 483 Form 483 | South Williamsport, Pennsylvania | 3 | $99 |
Investigators on these documents
About Duralife-USA, LLC
How many FDA Form 483s has Duralife-USA, LLC received?
FDA Intel has 1 Form 483 on file for Duralife-USA, LLC; the most recent is dated Feb 7, 2017.
When was Duralife-USA, LLC last inspected by FDA?
The most recent FDA inspection document on file for Duralife-USA, LLC is a Form 483 dated Feb 7, 2017, for the site in South Williamsport, Pennsylvania.
What did FDA cite at Duralife-USA, LLC?
The regulations cited most in the observations on file for Duralife-USA, 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 820.198 (Complaint files), 1 time; 21 CFR 820.20 (Management responsibility), 1 time.