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

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.