FDA 483 - Wells Pharmacy, Inc - January 28, 2021

This FDA Form 483 documents observations from an inspection, indicating several deficiencies in the facility's operations and quality systems. The firm failed to thoroughly review batch failures or components not meeting specifications, even for distributed batches. Persistent fungus mold recoveries were noted in production areas. The quality unit did not thoroughly review gowning results and associated released batch records.

The facility's buildings lacked suitable construction for cleaning, maintenance, and proper operations. Equipment and utensils were not maintained at appropriate intervals to prevent contamination. The quality control unit lacked responsibility for approving and rejecting procedures or specifications impacting drug product identity, strength, quality, and purity. Complaint records were deficient, missing investigation findings and follow-up. Individuals supervising manufacturing lacked adequate training to ensure drug product safety, identity, strength, quality, and purity. Additionally, the firm was found to be compounding drugs essentially copying approved drugs, which is a violation under sections 503B(a)(5) and 503B(d)(2).