Coram Healthcare Corp. of Indiana
Form 483 issued December 16, 2014 · Crown Point, Indiana
- Inspection
- Dec 16, 2014
- Investigators
- Michael Y. Philopoulos· Sarah M. Napier
- Observations
- 9
- Pages
- 5
- FEI number
- 3004593468
In short: On December 16, 2014, FDA issued a Form 483 with 9 observations to Coram Healthcare Corp. of Indiana in Crown Point, Indiana (FEI 3004593468) after an inspection that ran Dec 16, 2014. The investigators were Michael Y. Philopoulos and Sarah M. Napier. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
This inspection in context
Michael Y. Philopoulos
4 documents · 2014–2019
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Indiana.
The firmCoram Healthcare Corp. of Indiana history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Coram Healthcare Corp. of Indiana?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Coram Healthcare Corp. of Indiana?
Michael Y. Philopoulos and Sarah M. Napier are named on this Form 483, for the inspection of Dec 16, 2014. Each investigator has a profile showing what they cite most.
When was Coram Healthcare Corp. of Indiana inspected by FDA?
The inspection ran Dec 16, 2014, and the Form 483 is dated December 16, 2014.
How do I get the full Form 483 for Coram Healthcare Corp. of Indiana?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.