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

On August 16, 2018, an FDA Form 483 was issued to Quinn Pharmacy dba Northland Discount Drug Inc. in Laurel, MS, following an inspection 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:** 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 confirming cleanings are performed according to manufacturer recommendations.

2. **Inadequate containment for hazardous drugs:** Hazardous drugs were produced without sufficient containment, segregation, and/or cleaning of work surfaces, utensils, and personnel to prevent cross-contamination. The firm compounds hazardous drugs using non-dedicated equipment and could not provide documentation supporting cleanings between production batches of hazardous and non-hazardous drugs.

The inspection was conducted by Investigator June P. Page.