Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
Form 483 issued November 14, 2018 · Roseburg, Oregon
- Inspection
- Oct 29 – Nov 14, 2018
- Investigator
- Bryan L. McGuckin
- Observations
- 10
- Pages
- 9
- FEI number
- 3014745182
In short: On November 14, 2018, FDA issued a Form 483 with 10 observations to Hiers Enterprises, LLC dba Northwest Compounding Pharmacy in Roseburg, Oregon (FEI 3014745182) after an inspection that ran Oct 29 – Nov 14, 2018. 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 not…
- 02
Clothing of personnel engaged in the of drug products is not appropriate for…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
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 firmHiers Enterprises, LLC dba Northwest Compounding Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 Hiers Enterprises, LLC dba Northwest Compounding Pharmacy?
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 Hiers Enterprises, LLC dba Northwest Compounding Pharmacy?
Bryan L. McGuckin is named on this Form 483, for the inspection of Oct 29 – Nov 14, 2018. Each investigator has a profile showing what they cite most.
When was Hiers Enterprises, LLC dba Northwest Compounding Pharmacy inspected by FDA?
The inspection ran Oct 29 – Nov 14, 2018, and the Form 483 is dated November 14, 2018.
How do I get the full Form 483 for Hiers Enterprises, LLC dba Northwest Compounding 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.