> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# 7 Observations in Wells Pharmacy Inspection
- URL: https://www.fdaweb.com/7-observations-in-wells-pharmacy-inspection/
- Published: 2021-04-06T12:00:00.000Z
- Updated: 2026-09-14T16:53:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149046

FDA has released the FDA-483 issued following a 12/1/20-1/28/21 agency inspection at Wells Pharmacy, a Dyersburg, TN, outsourcing facility. The inspection’s seven observations were: 

- failing 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 already been distributed;
- 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 (repeat observation from 2018);
- failing to maintain equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
- the quality control unit lacks the responsibility to approve and reject all procedures or specifications affecting the identity, strength, quality, and purity of drug products (repeat observation from 2018);
- company records are deficient in that they do not include the findings of the investigation and follow-up;
- 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; and
- the facility compounds drugs that are essentially a copy of one or more approved drugs within the meaning of the law.