# FDA 483 - Hiers Enterprises, LLC dba Northwest Compounding Pharmacy - November 10, 2021

Source: https://www.globalkeysolutions.net/records/483/hiers-enterprises-llc-dba-northwest-compounding-pharmacy/6d7cf07c-ae6f-4ff3-88dd-30e1a1e607bc

> FDA 483 for Hiers Enterprises, LLC dba Northwest Compounding Pharmacy on November 10, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
- Inspection Date: 2021-11-10
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Hiers Enterprises, LLC dba Northwest Compounding Pharmacy in Roseburg, OR, revealed significant deficiencies in the production of non-sterile drug products. Observations included inadequate containment and cleaning practices for hazardous and beta-lactam drugs, leading to potential cross-contamination. Additionally, personnel failed to change gloves frequently enough, further compromising product integrity.

## Related Documents

- [STATE_REFERRAL_LETTER - 2021-11-02](https://www.globalkeysolutions.net/records/state_referral_letter/hiers-enterprises-llc-dba-northwest-compounding-pharmacy/89c4eadc-0741-444d-9036-6bc730fbe69c)

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.globalkeysolutions.net/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.globalkeysolutions.net/companies/hiers-enterprises-llc-dba-northwest-compounding-pharmacy/d97cbd91-b7d4-4499-886c-3d9a76efd049

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6