Ondamed Inc
FDA inspection history in Washingtonville, New York, 2015 to 2016
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2015: one warning letter; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–16One warning letter and one Form 483, at Washingtonville, New York.
Cited most
Across all Ondamed observations on file
- 21 CFR 820.30(f)Design controls2
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.184Device history record1
- 21 CFR 820.72(a)Inspection, measuring, and test equipment1
The complete Ondamed 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
Washingtonville, New York
One Form 483 · 2016 · 5 observations
Latest: Form 483, Aug 15, 2016 →
Also: one document not tied to a site.
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-08-15 | 483 Form 483 | Washingtonville, New York | 5 | $99 |
| 2015-06-01 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
FEI number 3011088301 · most recent document Aug 15, 2016
About Ondamed Inc
How many FDA Form 483s has Ondamed Inc received?
FDA Intel has 1 Form 483 on file for Ondamed Inc; the most recent is dated Aug 15, 2016.
When was Ondamed Inc last inspected by FDA?
The most recent FDA inspection document on file for Ondamed Inc is a Form 483 dated Aug 15, 2016, for the site in Washingtonville, New York.
What did FDA cite at Ondamed Inc?
The regulations cited most in the observations on file for Ondamed Inc are 21 CFR 820.30(f) (Design controls), 2 times; 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.184 (Device history record), 1 time.
Has Ondamed Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Ondamed Inc; the most recent is dated Jun 1, 2015.