Ondamed Inc
Form 483 issued August 15, 2016 · Washingtonville, New York
- Inspection
- Aug 1 – Aug 15, 2016
- Investigator
- Jacqueline S. Warner
- Observations
- 5
- Pages
- 5
- FEI number
- 3011088301
In short: On August 15, 2016, FDA issued a Form 483 with 5 observations to Ondamed Inc in Washingtonville, New York (FEI 3011088301) after an inspection that ran Aug 1 – Aug 15, 2016. The investigator was Jacqueline S. Warner. Most observations concern design controls and records & documents; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and records & documents account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design change have not been established. (a) A copy of Change Request (b) (4)…
- 02
The design verification results, including identification of the design, method(s), the date and the individual(s) performing…
- 03
The device history record does not demonstrate that the device was manufactured in accordance with the…
- 04
Procedures to ensure equipment is routinely calibrated and maintained have…
This inspection in context
Jacqueline S. Warner
7 documents · 2008–2024
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in New York.
The firmOndamed 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 820.30(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ondamed Inc?
FDA listed 5 observations on this Form 483, mostly about design controls, records & documents 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 Ondamed Inc?
Jacqueline S. Warner is named on this Form 483, for the inspection of Aug 1 – Aug 15, 2016. Each investigator has a profile showing what they cite most.
When was Ondamed Inc inspected by FDA?
The inspection ran Aug 1 – Aug 15, 2016, and the Form 483 is dated August 15, 2016.
How do I get the full Form 483 for Ondamed 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.