Parks Medical Electronics
Form 483 issued June 17, 2016 · Aloha, Oregon
- Inspection
- Jun 6 – Jun 17, 2016
- Investigators
- Celia L. Silverstein· Stanley B. Eugene
- Observations
- 4
- Pages
- 5
- FEI number
- 3020115
In short: On June 17, 2016, FDA issued a Form 483 with 4 observations to Parks Medical Electronics in Aloha, Oregon (FEI 3020115) after an inspection that ran Jun 6 – Jun 17, 2016. The investigators were Celia L. Silverstein and Stanley B. Eugene. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The results of design validation, including method(s>), the date and the individual(s) performing validation , were…
- 02
The design verification results, including method(s), were not adequately documented in…
- 03
Procedures to ensure equipment is routinely calibrated and maintained have…
- 04
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Celia L. Silverstein
1 document · 2016
Cites 820.30(f) (design controls) more than any other section. Most of their documents are for sites in Oregon.
The firmParks Medical Electronics history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Parks Medical Electronics?
FDA listed 4 observations on this Form 483, mostly about design controls and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Parks Medical Electronics?
Celia L. Silverstein and Stanley B. Eugene are named on this Form 483, for the inspection of Jun 6 – Jun 17, 2016. Each investigator has a profile showing what they cite most.
When was Parks Medical Electronics inspected by FDA?
The inspection ran Jun 6 – Jun 17, 2016, and the Form 483 is dated June 17, 2016.
How do I get the full Form 483 for Parks Medical Electronics?
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.