Miramar Labs, Inc
FDA inspection history in Santa Clara, California, 2015
- 1
- Form 483
Every document, by year
- Form 483
2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Santa Clara, California.
Cited most
Across all Miramar Labs observations on file
- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?2
- 21 CFR 820.30(g)Design controls2
The complete Miramar Labs file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Santa Clara, California
One Form 483 · 2015 · 4 observations
Latest: Form 483, Aug 17, 2015 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-08-17 | 483 Form 483 | Santa Clara, California | 4 | $99 |
Investigators on these documents
FEI number 3008082710 · most recent document Aug 17, 2015
About Miramar Labs, Inc
How many FDA Form 483s has Miramar Labs, Inc received?
FDA Intel has 1 Form 483 on file for Miramar Labs, Inc; the most recent is dated Aug 17, 2015.
When was Miramar Labs, Inc last inspected by FDA?
The most recent FDA inspection document on file for Miramar Labs, Inc is a Form 483 dated Aug 17, 2015, for the site in Santa Clara, California.
What did FDA cite at Miramar Labs, Inc?
The regulations cited most in the observations on file for Miramar Labs, Inc are 21 CFR 803.50(a)(1) (If I am a manufacturer, what reporting requirements apply to me?), 2 times; 21 CFR 820.30(g) (Design controls), 2 times.