Powers Medical Devices, LLC
FDA inspection history in Boca Raton, Florida, 2016
- 1
- Form 483
Every document, by year
- Form 483
2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Boca Raton, Florida.
Cited most
Across all Powers Medical Devices observations on file
- 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 820.198(a)Complaint files1
- 21 CFR 820.20(e)Management responsibility1
- 21 CFR 820.22Quality audit1
The complete Powers Medical Devices file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Boca Raton, Florida
One Form 483 · 2016 · 6 observations
Latest: Form 483, Sep 8, 2016 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-09-08 | 483 Form 483 | Boca Raton, Florida | 6 | $99 |
Investigators on these documents
FEI number 3009199231 · most recent document Sep 8, 2016
About Powers Medical Devices, LLC
How many FDA Form 483s has Powers Medical Devices, LLC received?
FDA Intel has 1 Form 483 on file for Powers Medical Devices, LLC; the most recent is dated Sep 8, 2016.
When was Powers Medical Devices, LLC last inspected by FDA?
The most recent FDA inspection document on file for Powers Medical Devices, LLC is a Form 483 dated Sep 8, 2016, for the site in Boca Raton, Florida.
What did FDA cite at Powers Medical Devices, LLC?
The regulations cited most in the observations on file for Powers Medical Devices, LLC are 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; 21 CFR 820.198(a) (Complaint files), 1 time.