Custom Ultrasonics, Inc.
Form 483 issued April 24, 2015 · Ivyland, Pennsylvania
- Inspection
- Apr 9 – Apr 24, 2015
- Investigators
- Brian S. Keefer· Daniel W. Johnson
- Observations
- 1
- Pages
- 3
- FEI number
- 2523209
In short: On April 24, 2015, FDA issued a Form 483 with 1 observation to Custom Ultrasonics, Inc. in Ivyland, Pennsylvania (FEI 2523209) after an inspection that ran Apr 9 – Apr 24, 2015. The investigators were Brian S. Keefer and Daniel W. Johnson. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Brian S. Keefer
6 documents · 2011–2019
Cites 118.10(a)(3)(iv) (recordkeeping requirements for the salmonella enteritidis (se) prevention plan) 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 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Custom Ultrasonics, Inc.?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Custom Ultrasonics, Inc.?
Brian S. Keefer and Daniel W. Johnson are named on this Form 483, for the inspection of Apr 9 – Apr 24, 2015. Each investigator has a profile showing what they cite most.
When was Custom Ultrasonics, Inc. inspected by FDA?
The inspection ran Apr 9 – Apr 24, 2015, and the Form 483 is dated April 24, 2015.
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.