Respironics California Inc
FDA inspection history in Carlsbad, California, 2004 to 2016
- 2
- Warning letters
- 1
- Form 483
Every document, by year
- Form 483
- Warning letter
2004: one warning letter; 2014: one warning letter; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2004One warning letter, at Carlsbad, California.
- 2014–16One warning letter and one Form 483, at Carlsbad, California.
Cited most
Across all Respironics California observations on file
- 21 CFR 820.100Corrective and preventive action2
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 806.10Reports of corrections and removals1
The complete Respironics California 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
Carlsbad, California
Two warning letters and one Form 483 · 2004 to 2016 · 4 observations
Latest: Form 483, Jan 15, 2016 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-01-15 | 483 Form 483 | Carlsbad, California | 4 | $99 |
| 2014-11-17 | Warning letter Warning letter | Carlsbad, California | — | $99 |
| 2004-01-27 | Warning letter Warning letter | Carlsbad, California | — | $99 |
Investigators on these documents
Joey V. Quitania (1)Shaquenta Y. Perkins (1)Virgilio F. Pacio (1)
FEI number 3002470603 · most recent document Jan 15, 2016
About Respironics California Inc
How many FDA Form 483s has Respironics California Inc received?
FDA Intel has 1 Form 483 on file for Respironics California Inc; the most recent is dated Jan 15, 2016.
When was Respironics California Inc last inspected by FDA?
The most recent FDA inspection document on file for Respironics California Inc is a Form 483 dated Jan 15, 2016, for the site in Carlsbad, California.
What did FDA cite at Respironics California Inc?
The regulations cited most in the observations on file for Respironics California Inc are 21 CFR 820.100 (Corrective and preventive action), 2 times; 21 CFR 803.50 (If I am a manufacturer, what reporting requirements apply to me?), 1 time; 21 CFR 806.10 (Reports of corrections and removals), 1 time.
Has Respironics California Inc received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Respironics California Inc; the most recent is dated Nov 17, 2014.