Circulatory Technology Inc
FDA inspection history in Oyster Bay, New York, 2010 to 2019
- 1
- Close-out
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2010: one warning letter; 2016: one Form 483; 2019: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One warning letter, at Oyster Bay, New York.
- 2016One Form 483, at Oyster Bay, New York.
- 2019One close-out letter, at Oyster Bay, New York.
Cited most
Across all Circulatory Technology observations on file
- 21 CFR 820.30(b)Design controls4
- 21 CFR 8201
- 21 CFR 803.18(e)What are the requirements for establishing and maintaining MDR files or records that apply to me?1
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.100(b)Corrective and preventive action1
The complete Circulatory Technology 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
Oyster Bay, New York
One close-out letter, one Form 483 and one warning letter · 2010 to 2019 · 10 observations
Latest: Close-out, Jan 28, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-01-28 | Close-out Close-out letter | Oyster Bay, New York | — | $99 |
| 2016-07-08 | 483 Form 483 | Oyster Bay, New York | 10 | $99 |
| 2010-07-12 | Warning letter Warning letter | Oyster Bay, New York | — | $99 |
Investigators on these documents
FEI number 1000522036 · most recent document Jan 28, 2019
About Circulatory Technology Inc
How many FDA Form 483s has Circulatory Technology Inc received?
FDA Intel has 1 Form 483 on file for Circulatory Technology Inc; the most recent is dated Jul 8, 2016.
When was Circulatory Technology Inc last inspected by FDA?
The most recent FDA inspection document on file for Circulatory Technology Inc is a Form 483 dated Jul 8, 2016, for the site in Oyster Bay, New York.
What did FDA cite at Circulatory Technology Inc?
The regulations cited most in the observations on file for Circulatory Technology Inc are 21 CFR 820.30(b) (Design controls), 4 times; 21 CFR 820, 1 time; 21 CFR 803.18(e) (What are the requirements for establishing and maintaining MDR files or records that apply to me?), 1 time.
Has Circulatory Technology Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Circulatory Technology Inc; the most recent is dated Jul 12, 2010.