Conceptus, Inc.
Form 483 issued January 6, 2011 · Mountain View, California
- Inspection
- Dec 8, 2010 – Jan 6, 2011
- Investigator
- Timothy C. Grome
- Observations
- 4
- Pages
- 4
- FEI number
- 1000221357
In short: On January 6, 2011, FDA issued a Form 483 with 4 observations to Conceptus, Inc. in Mountain View, California (FEI 1000221357) after an inspection that ran Dec 8, 2010 – Jan 6, 2011. The investigator was Timothy C. Grome. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
3 of 4 observations on this 483 concern capa.
Most cited: 21 CFR 803.50 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 03
Risk analysis is…
- 04
Corrective and preventive action activities and/or results…
This inspection in context
Timothy C. Grome
3 documents · 2011–2015
Cites 803.50 (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in California.
The firmConceptus, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Conceptus, Inc.?
FDA listed 4 observations on this Form 483, mostly about cAPA and design controls. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Conceptus, Inc.?
Timothy C. Grome is named on this Form 483, for the inspection of Dec 8, 2010 – Jan 6, 2011. Each investigator has a profile showing what they cite most.
When was Conceptus, Inc. inspected by FDA?
The inspection ran Dec 8, 2010 – Jan 6, 2011, and the Form 483 is dated January 6, 2011.
How do I get the full Form 483 for Conceptus, 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.