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Form 483

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy Form 483, 2021-11-10

FDA issued a Form 483 to Hiers Enterprises, LLC dba Northwest Compounding Pharmacy on 2021-11-10 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy · Roseburg, United States · Issued November 10, 2021

Overview

  • 3 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

10 Nov 2021
FDCA 501(a)(2)(A)

Beta-lactam drugs, inadequate sanitation

Cited by Christopher R Czajka

10 Nov 2021
FDCA 501(a)(2)(A)

Hazardous drugs, prevention of cross-contamination

Cited by Christopher R Czajka

10 Nov 2021
FDCA 501(a)(2)(A)

Personnel habits, contamination

Cited by Christopher R Czajka

Inspected site

HEHiers Enterprises, LLC dba Northwest Compounding PharmacyRoseburg, United States

Inspection team

CRChristopher R Czajka

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
FDCA 501(a)(2)(A)Cited across public-safe Form 483 observations3x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 3 observations

The source PDF, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere