Region Care Inc. (Northwell Health)
FDA inspection history in Great Neck, New York, 2006 to 2016
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2006: one Form 483; 2015: one warning letter; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2006One Form 483, at Great Neck, New York.
- 2015–16One warning letter and one Form 483, at Great Neck, New York.
- 2016The longest 483 on file: 8 observations over 4 pages at Great Neck, New York.
Cited most
Across all Region Care Inc. (Northwell Health) observations on file
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.160General requirements2
- 21 CFR 211.167Special testing requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.28Personnel responsibilities2
The complete Region Care Inc. (Northwell Health) 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
Great Neck, New York
Two Form 483s and one warning letter · 2006 to 2016 · 15 observations
Latest: Form 483, Jun 10, 2016 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-06-10 | 483 Form 483 | Great Neck, New York | 8 | $99 |
| 2015-04-08 | Warning letter Warning letter | Great Neck, New York | — | $99 |
| 2006-04-05 | 483 Form 483 | Great Neck, New York | 7 | $99 |
Investigators on these documents
FEI number 3005287250 · most recent document Jun 10, 2016
About Region Care Inc. (Northwell Health)
How many FDA Form 483s has Region Care Inc. (Northwell Health) received?
FDA Intel has 2 Form 483s on file for Region Care Inc. (Northwell Health); the most recent is dated Jun 10, 2016.
When was Region Care Inc. (Northwell Health) last inspected by FDA?
The most recent FDA inspection document on file for Region Care Inc. (Northwell Health) is a Form 483 dated Jun 10, 2016, for the site in Great Neck, New York.
What did FDA cite at Region Care Inc. (Northwell Health)?
The regulations cited most in the observations on file for Region Care Inc. (Northwell Health) are 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.167 (Special testing requirements), 2 times.
Has Region Care Inc. (Northwell Health) received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Region Care Inc. (Northwell Health); the most recent is dated Apr 8, 2015.