Edwards Lifesciences Technology SARL
FDA inspection history in Anasco, Puerto Rico, 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 Anasco, Puerto Rico.
Cited most
Across all Edwards Lifesciences Technology SARL observations on file
- 21 CFR 211.103Calculation of yield1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.170(b)Reserve samples1
- 21 CFR 820.100(a)Corrective and preventive action1
The complete Edwards Lifesciences Technology SARL file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Anasco, Puerto Rico
One Form 483 · 2015 · 8 observations
Latest: Form 483, Jan 27, 2015 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-01-27 | 483 Form 483 | Anasco, Puerto Rico | 8 | $99 |
Investigators on these documents
FEI number 2648045 · most recent document Jan 27, 2015
About Edwards Lifesciences Technology SARL
How many FDA Form 483s has Edwards Lifesciences Technology SARL received?
FDA Intel has 1 Form 483 on file for Edwards Lifesciences Technology SARL; the most recent is dated Jan 27, 2015.
When was Edwards Lifesciences Technology SARL last inspected by FDA?
The most recent FDA inspection document on file for Edwards Lifesciences Technology SARL is a Form 483 dated Jan 27, 2015, for the site in Anasco, Puerto Rico.
What did FDA cite at Edwards Lifesciences Technology SARL?
The regulations cited most in the observations on file for Edwards Lifesciences Technology SARL are 21 CFR 211.103 (Calculation of yield), 1 time; 21 CFR 211.165(a) (Testing and release for distribution), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time.