Carepoint Healthcare, LLC, dba Carepoint Pharmacy
Form 483 issued August 2, 2017 · Schaumburg, Illinois
- Inspection
- Jul 27 – Aug 2, 2017
- Investigators
- Bryan L. McGuckin· Debra I. Love
- Observations
- 4
- Pages
- 5
- FEI number
- 3013441865
In short: On August 2, 2017, FDA issued a Form 483 with 4 observations to Carepoint Healthcare, LLC, dba Carepoint Pharmacy in Schaumburg, Illinois (FEI 3013441865) after an inspection that ran Jul 27 – Aug 2, 2017. The investigators were Bryan L. McGuckin and Debra I. Love. 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×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel engaged in aseptic processing did not use aseptic techniques to ensure…
- 02
Equipment, materials, and/or supplies are not disinfected prior to entering…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Media Fills are performed in a manner that does not closely simulate production operations at the…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmCarepoint Healthcare, LLC, dba Carepoint Pharmacy history
The site's inspection history, in date order.
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 Carepoint Healthcare, LLC, dba Carepoint Pharmacy?
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 Carepoint Healthcare, LLC, dba Carepoint Pharmacy?
Bryan L. McGuckin and Debra I. Love are named on this Form 483, for the inspection of Jul 27 – Aug 2, 2017. Each investigator has a profile showing what they cite most.
When was Carepoint Healthcare, LLC, dba Carepoint Pharmacy inspected by FDA?
The inspection ran Jul 27 – Aug 2, 2017, and the Form 483 is dated August 2, 2017.
How do I get the full Form 483 for Carepoint Healthcare, LLC, dba Carepoint Pharmacy?
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.