Coram Healthcare Corp. of Indiana
FDA inspection history across 2 sites, 2014 to 2017
- 2
- Form 483s
- 1
- Response
- 1
- Warning letter
Every document, by year
- Response
- Form 483
- Warning letter
2014: one Form 483; 2015: one warning letter; 2017: one 483 response and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–17Two Form 483s, one warning letter and one 483 response, at Crown Point, Indiana and Indiana.
- 2014The longest 483 on file: 9 observations over 5 pages at Crown Point, Indiana.
Cited most
Across all Coram Healthcare Corp. of Indiana observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.42(c)(10)(iv)Design and construction features3
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.167(a)Special testing requirements1
The complete Coram Healthcare Corp. of Indiana file.
All 4 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
Crown Point, Indiana
Two Form 483s and one warning letter · 2014 to 2017 · 13 observations
Latest: Form 483, Apr 26, 2017 →Indiana
One 483 response · 2017
Latest: Response, Aug 8, 2017 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-08-08 | Response 483 response | Indiana | — | $199 |
| 2017-04-26 | 483 Form 483 | Crown Point, Indiana | 4 | $99 |
| 2015-08-11 | Warning letter Warning letter | Crown Point, Indiana | — | $99 |
| 2014-12-16 | 483 Form 483 | Crown Point, Indiana | 9 | $99 |
Investigators on these documents
Emilie Kahn (1)Michael Y. Philopoulos (1)Sarah E. Rhoades (1)Sarah M. Napier (1)
FEI number 3004593468 · most recent document Aug 8, 2017
About Coram Healthcare Corp. of Indiana
How many FDA Form 483s has Coram Healthcare Corp. of Indiana received?
FDA Intel has 2 Form 483s on file for Coram Healthcare Corp. of Indiana; the most recent is dated Apr 26, 2017.
When was Coram Healthcare Corp. of Indiana last inspected by FDA?
The most recent FDA inspection document on file for Coram Healthcare Corp. of Indiana is a Form 483 dated Apr 26, 2017, for the site in Crown Point, Indiana.
What did FDA cite at Coram Healthcare Corp. of Indiana?
The regulations cited most in the observations on file for Coram Healthcare Corp. of Indiana are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.42(c)(10)(iv) (Design and construction features), 3 times; 21 CFR 211.165(a) (Testing and release for distribution), 1 time.
Has Coram Healthcare Corp. of Indiana received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Coram Healthcare Corp. of Indiana; the most recent is dated Aug 11, 2015.