Macfarlan Smith Cited for GMP Deficiencies

API manufacturer Macfarlan Smith drew a Form 483 from the FDA for failing to ensure products manufactured at its Edinburgh, Scotland facility met current good manufacturing practice requirements.

An October inspection determined that the firm’s quality unit did not ensure the active pharmaceutical ingredients it manufactured were compliant with CGMPs.

In one instance, a product batch was rejected because of the consistency and quality of an ingredient used in its manufacturing. The component’s supplier was disqualified, but there was no documented attempt by Macfarlan Smith to review previously distributed products that had used the ingredient.