Nova Biomedical Corporation
Form 483 issued April 4, 2017 · Waltham, Massachusetts
- Inspection
- Mar 23 – Apr 4, 2017
- Investigators
- Justine M. Corson· Suzanne M. Healy
- Observations
- 2
- Pages
- 4
In short: On April 4, 2017, FDA issued a Form 483 with 2 observations to Nova Biomedical Corporation in Waltham, Massachusetts after an inspection that ran Mar 23 – Apr 4, 2017. The investigators were Justine M. Corson and Suzanne M. Healy. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×) · 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action…
- 02
Complaint files are not…
This inspection in context
Justine M. Corson
5 documents · 2012–2019
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmNova Biomedical Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nova Biomedical Corporation?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Nova Biomedical Corporation?
Justine M. Corson and Suzanne M. Healy are named on this Form 483, for the inspection of Mar 23 – Apr 4, 2017. Each investigator has a profile showing what they cite most.
When was Nova Biomedical Corporation inspected by FDA?
The inspection ran Mar 23 – Apr 4, 2017, and the Form 483 is dated April 4, 2017.
How do I get the full Form 483 for Nova Biomedical Corporation?
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.