HomeChoice Partners, Inc. dba Bioscrip
Form 483 issued September 19, 2018 · Chesterfield, Missouri
- Inspection
- Sep 10 – Sep 19, 2018
- Investigator
- Tiara N. Brown-Crosen
- Observations
- 2
- Pages
- 2
- FEI number
- 3014088548
In short: On September 19, 2018, FDA issued a Form 483 with 2 observations to HomeChoice Partners, Inc. dba Bioscrip in Chesterfield, Missouri (FEI 3014088548) after an inspection that ran Sep 10 – Sep 19, 2018. The investigator was Tiara N. Brown-Crosen. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You produced beta-lactam drugs without providing adequate cleaning of work surfaces…
- 02
Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area…
This inspection in context
Tiara N. Brown-Crosen
7 documents · 2016–2019
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in Missouri.
The firmHomeChoice Partners, Inc. dba Bioscrip history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at HomeChoice Partners, Inc. dba Bioscrip?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected HomeChoice Partners, Inc. dba Bioscrip?
Tiara N. Brown-Crosen is named on this Form 483, for the inspection of Sep 10 – Sep 19, 2018. Each investigator has a profile showing what they cite most.
When was HomeChoice Partners, Inc. dba Bioscrip inspected by FDA?
The inspection ran Sep 10 – Sep 19, 2018, and the Form 483 is dated September 19, 2018.
How do I get the full Form 483 for HomeChoice Partners, Inc. dba Bioscrip?
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.