Wells Pharmacy, Inc — FDA 483 Findings

Individuals responsible for supervising the manufacture, processing, packing and holding of a drug product lack the training to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.

Your outsourcing facility has not submitted an adverse event report to FDA in accordance with the content and format requirements established through guidance or regulation under 21 CFR 310.305 as required by section SOJB(b)(S).

Complaint records are deficient in that they do not include the findings of the investigation and follow-up.

There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Specifically, during an intetview with your firm's Quality Assurance Supervisor, who is onsite daily, is responsible for, but not limited to: review and release of your firm's batch records; routine monitoring reviews; and oversees your firm's environmental monitoring program, stated they do not make quality decisions due to lack of experience or authority.

The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.

for additional Quality Unit concerns.

Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.

Specifically, your firm has structural and equipment deficiencies in the classified areas which do not ensure clean airflow, including, but are not limited to

You compound drugs that are essentially a copy of one or more approved drugs within the meaning of sections 503B(a)(5) and 503B(d)(2).

Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.