Custom Ultrasonics, Inc.
FDA inspection history in Ivyland, Pennsylvania, 2014 to 2015
- 2
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–15Two Form 483s, at Ivyland, Pennsylvania.
- 2014The longest 483 on file: 8 observations over 5 pages at Ivyland, Pennsylvania.
Cited most
Across all Custom Ultrasonics observations on file
- 21 CFR 820.30(f)Design controls2
- 21 CFR 820.75(a)Process validation2
- 21 CFR 820.184(d)Device history record1
- 21 CFR 820.20Management responsibility1
- 21 CFR 820.40(a)Document controls1
The complete Custom Ultrasonics 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
Ivyland, Pennsylvania
Two Form 483s · 2014 to 2015 · 9 observations
Latest: Form 483, Apr 24, 2015 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-04-24 | 483 Form 483 | Ivyland, Pennsylvania | 1 | $99 |
| 2014-11-19 | 483 Form 483 | Ivyland, Pennsylvania | 8 | $99 |
Investigators on these documents
Brian S. Keefer (1)Daniel W. Johnson (1)Edward D. McDonald (1)
FEI number 2523209 · most recent document Apr 24, 2015
About Custom Ultrasonics, Inc.
How many FDA Form 483s has Custom Ultrasonics, Inc. received?
FDA Intel has 2 Form 483s on file for Custom Ultrasonics, Inc.; the most recent is dated Apr 24, 2015.
When was Custom Ultrasonics, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Custom Ultrasonics, Inc. is a Form 483 dated Apr 24, 2015, for the site in Ivyland, Pennsylvania.
What did FDA cite at Custom Ultrasonics, Inc.?
The regulations cited most in the observations on file for Custom Ultrasonics, Inc. are 21 CFR 820.30(f) (Design controls), 2 times; 21 CFR 820.75(a) (Process validation), 2 times; 21 CFR 820.184(d) (Device history record), 1 time.