Parks Medical Electronics
FDA inspection history in Aloha, Oregon, 2012 to 2016
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2012: one warning letter; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012One warning letter, at Aloha, Oregon.
- 2016One Form 483, at Aloha, Oregon.
Cited most
Across all Parks Medical Electronics observations on file
- 21 CFR 820.30(f)Design controls2
- 21 CFR 820.50Purchasing controls1
- 21 CFR 820.72(a)Inspection, measuring, and test equipment1
The complete Parks Medical Electronics file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Aloha, Oregon
One Form 483 and one warning letter · 2012 to 2016 · 4 observations
Latest: Form 483, Jun 17, 2016 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-06-17 | 483 Form 483 | Aloha, Oregon | 4 | $99 |
| 2012-11-27 | Warning letter Warning letter | Aloha, Oregon | — | $99 |
Investigators on these documents
FEI number 3020115 · most recent document Jun 17, 2016
About Parks Medical Electronics
How many FDA Form 483s has Parks Medical Electronics received?
FDA Intel has 1 Form 483 on file for Parks Medical Electronics; the most recent is dated Jun 17, 2016.
When was Parks Medical Electronics last inspected by FDA?
The most recent FDA inspection document on file for Parks Medical Electronics is a Form 483 dated Jun 17, 2016, for the site in Aloha, Oregon.
What did FDA cite at Parks Medical Electronics?
The regulations cited most in the observations on file for Parks Medical Electronics are 21 CFR 820.30(f) (Design controls), 2 times; 21 CFR 820.50 (Purchasing controls), 1 time; 21 CFR 820.72(a) (Inspection, measuring, and test equipment), 1 time.
Has Parks Medical Electronics received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Parks Medical Electronics; the most recent is dated Nov 27, 2012.