North Laurel Discount Pharmacy, Inc DBA Quinn Pharmacy – FDA 483, Aug 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.