# FDA 483 - North Laurel Discount Pharmacy, Inc DBA Quinn Pharmacy - August 16, 2018

Source: https://www.keypedia.com/records/483/north-laurel-discount-pharmacy-inc-dba-quinn-pharmacy/d93a776f-e9e9-4136-81af-598d1df71228

> FDA 483 for North Laurel Discount Pharmacy, Inc DBA Quinn Pharmacy on August 16, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: North Laurel Discount Pharmacy, Inc DBA Quinn Pharmacy
- Inspection Date: 2018-08-16
- Product Type: Drugs
- Summary: On August 16, 2018, the FDA issued a Form 483 to Quinn Pharmacy dba Northland Discount Drug Inc. of Laurel, MS, following an inspection conducted from August 14-16, 2018. The firm is identified as a producer of non-sterile drugs.

Two observations were noted:

1.  **Non-pharmaceutical grade components used in non-sterile drug products:** The firm uses a (b)(4) system for producing Sodium Bicarbonate and Omeprazole, but lacked documentation supporting the (b)(4) used in production. No microbial testing is conducted on drug products utilizing this system. Additionally, the Pharmacist-in-Charge could not provide documentation of cleanings performed according to manufacturer recommendations for this system.

2.  **Inadequate containment, segregation, and/or cleaning for hazardous drug production:** The firm compounds hazardous drugs using non-dedicated equipment. There was no documentation to support that cleanings were conducted between production batches of hazardous drugs and non-hazardous drugs, raising concerns about potential cross-contamination.

These observations highlight deficiencies in component quality control, microbial testing, equipment cleaning validation, and cross-contamination prevention for both non-sterile and hazardous drug compounding operations.

## Related Documents

- [483 - 2018-08-16](https://www.keypedia.com/records/483/north-laurel-discount-pharmacy-inc-dba-quinn-pharmacy/bf43e47d-e4cb-47d8-8e65-bc590b3e807b)

## Related Officers

- [June P. Page](https://www.keypedia.com/people/june-p-page/3b1ffc71-ce2e-47f5-aefe-87fd5eebc792)

Company: https://www.keypedia.com/companies/north-laurel-discount-pharmacy-inc-dba-quinn-pharmacy/94911408-882a-46ba-82cf-5cc09bd8e336