Covidien
FDA inspection history in Ponce, Puerto Rico, 2014
- 1
- Form 483
Every document, by year
- Form 483
2014: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One Form 483, at Ponce, Puerto Rico.
Cited most
Across all Covidien observations on file
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
The complete Covidien file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Ponce, Puerto Rico
One Form 483 · 2014 · 2 observations
Latest: Form 483, Aug 27, 2014 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2014-08-27 | 483 Form 483 | Ponce, Puerto Rico | 2 | $99 |
Investigators on these documents
FEI number 2647580 · most recent document Aug 27, 2014
About Covidien
How many FDA Form 483s has Covidien received?
FDA Intel has 1 Form 483 on file for Covidien; the most recent is dated Aug 27, 2014.
When was Covidien last inspected by FDA?
The most recent FDA inspection document on file for Covidien is a Form 483 dated Aug 27, 2014, for the site in Ponce, Puerto Rico.
What did FDA cite at Covidien?
The regulations cited most in the observations on file for Covidien are 21 CFR 803.50(a)(2) (If I am a manufacturer, what reporting requirements apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.