Health Solutions Pharmacy Center, Inc.
Form 483 issued January 28, 2019 · Corvallis, Oregon
- Inspection
- Dec 10, 2018 – Jan 28, 2019
- Investigator
- Bryan L. McGuckin
- Observations
- 10
- Pages
- 8
- FEI number
- 3014597434
In short: On January 28, 2019, FDA issued a Form 483 with 10 observations to Health Solutions Pharmacy Center, Inc. in Corvallis, Oregon (FEI 3014597434) after an inspection that ran Dec 10, 2018 – Jan 28, 2019. The investigator was Bryan L. McGuckin. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Laboratory controls and facilities & equipment account for 7 of 10 observations.
Most cited: 21 CFR 211.42 (3×) · 211.165 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
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 firmHealth Solutions Pharmacy Center, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Health Solutions Pharmacy Center, Inc.?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, facilities & equipment 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 Health Solutions Pharmacy Center, Inc.?
Bryan L. McGuckin is named on this Form 483, for the inspection of Dec 10, 2018 – Jan 28, 2019. Each investigator has a profile showing what they cite most.
When was Health Solutions Pharmacy Center, Inc. inspected by FDA?
The inspection ran Dec 10, 2018 – Jan 28, 2019, and the Form 483 is dated January 28, 2019.
How do I get the full Form 483 for Health Solutions Pharmacy Center, Inc.?
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.