Coram Healthcare Corp. of Indiana
Form 483 issued April 26, 2017 · Crown Point, Indiana
- Inspection
- Apr 17 – Apr 26, 2017
- Investigators
- Emilie Kahn· Sarah E. Rhoades
- Observations
- 4
- Pages
- 2
- FEI number
- 3004593468
In short: On April 26, 2017, FDA issued a Form 483 with 4 observations to Coram Healthcare Corp. of Indiana in Crown Point, Indiana (FEI 3004593468) after an inspection that ran Apr 17 – Apr 26, 2017. The investigators were Emilie Kahn and Sarah E. Rhoades. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment, materials, and/or supplies are not disinfected prior to enterin g the…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Beta-lactam drugs are produced without adequate cleaning procedures…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Emilie Kahn
15 documents · 2016–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
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 211.113
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 4 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Coram Healthcare Corp. of Indiana?
Emilie Kahn and Sarah E. Rhoades are named on this Form 483, for the inspection of Apr 17 – Apr 26, 2017. Each investigator has a profile showing what they cite most.
When was Coram Healthcare Corp. of Indiana inspected by FDA?
The inspection ran Apr 17 – Apr 26, 2017, and the Form 483 is dated April 26, 2017.
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.