Custom Ultrasonics, Inc.
Form 483 issued November 19, 2014 · Ivyland, Pennsylvania
- Inspection
- Oct 16 – Nov 19, 2014
- Investigator
- Edward D. McDonald
- Observations
- 8
- Pages
- 5
- FEI number
- 2523209
In short: On November 19, 2014, FDA issued a Form 483 with 8 observations to Custom Ultrasonics, Inc. in Ivyland, Pennsylvania (FEI 2523209) after an inspection that ran Oct 16 – Nov 19, 2014. The investigator was Edward D. McDonald. Most observations concern production & process controls and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Production & process controls and design controls account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Management with executive responsibility bas not ensured that an adequate and effective quality system has been…
- 02
Acceptance criteria were not documented prior to the…
- 03
Procedures were not completed to ensure that the device design was…
- 04
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Edward D. McDonald
8 documents · 2014–2026
Cites 820.20 (management responsibility) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmCustom Ultrasonics, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.20
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Custom Ultrasonics, Inc.?
FDA listed 8 observations on this Form 483, mostly about production & process controls, design controls and records & documents. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Custom Ultrasonics, Inc.?
Edward D. McDonald is named on this Form 483, for the inspection of Oct 16 – Nov 19, 2014. Each investigator has a profile showing what they cite most.
When was Custom Ultrasonics, Inc. inspected by FDA?
The inspection ran Oct 16 – Nov 19, 2014, and the Form 483 is dated November 19, 2014.
How do I get the full Form 483 for Custom Ultrasonics, Inc.?
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.