Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
Form 483 issued November 10, 2021 · Roseburg, Oregon
- Inspection
- Nov 2 – Nov 10, 2021
- Investigator
- Christopher R. Czajka
- Observations
- 3
- Pages
- 6
- FEI number
- 3014745182
In short: On November 10, 2021, FDA issued a Form 483 with 3 observations to Hiers Enterprises, LLC dba Northwest Compounding Pharmacy in Roseburg, Oregon (FEI 3014745182) after an inspection that ran Nov 2 – Nov 10, 2021. The investigator was Christopher R. Czajka.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
You produced hazardous dmgs without providing adequate containment and cleaning of…
- 02FDCA 501(a)(2)(A)
You produced beta-lactam drugs without providing adequate containment, segregation, cleaning of work surfaces and cleaning of…
- 03FDCA 501(a)(2)(A)
Personnel did not change gloves frequently…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
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.
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Questions about this 483
What did FDA find at Hiers Enterprises, LLC dba Northwest Compounding Pharmacy?
FDA listed 3 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Hiers Enterprises, LLC dba Northwest Compounding Pharmacy?
Christopher R. Czajka is named on this Form 483, for the inspection of Nov 2 – Nov 10, 2021. 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 Nov 2 – Nov 10, 2021, and the Form 483 is dated November 10, 2021.
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.