Conceptus, Inc.
FDA inspection history across 2 sites, 2002 to 2013
- 2
- EIRs
- 1
- Form 483
Every document, by year
- EIR
- Form 483
2002: one inspection report; 2011: one Form 483; 2013: one inspection report.
The story so far
Built from the dates and citations on the documents themselves.
- 2002One inspection report, at San Carlos, California.
- 2011–13One Form 483 and one inspection report, at Mountain View, California.
Cited most
Across all Conceptus observations on file
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?2
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.30Design controls1
The complete Conceptus file.
All 3 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
Mountain View, California
One inspection report and one Form 483 · 2011 to 2013 · 4 observations
Latest: EIR, Jun 26, 2013 →San Carlos, California
One inspection report · 2002
Latest: EIR, Jul 11, 2002 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2013-06-26 | EIR EIR | Mountain View, California | — | $550 |
| 2011-01-06 | 483 Form 483 | Mountain View, California | 4 | $99 |
| 2002-07-11 | EIR EIR | San Carlos, California | — | $550 |
Investigators on these documents
Timothy C. Grome (2)Barbara A. Crowl (1)Gerald N. McGirl (1)
FEI number 1000221357 · most recent document Jun 26, 2013
About Conceptus, Inc.
How many FDA Form 483s has Conceptus, Inc. received?
FDA Intel has 1 Form 483 on file for Conceptus, Inc.; the most recent is dated Jan 6, 2011.
When was Conceptus, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Conceptus, Inc. is an establishment inspection report (EIR) dated Jun 26, 2013, for the site in Mountain View, California.
What did FDA cite at Conceptus, Inc.?
The regulations cited most in the observations on file for Conceptus, Inc. are 21 CFR 803.50 (If I am a manufacturer, what reporting requirements apply to me?), 2 times; 21 CFR 820.100 (Corrective and preventive action), 1 time; 21 CFR 820.30 (Design controls), 1 time.