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.
The facility also failed to conduct timely product quality reviews and quality investigations. Corrective actions for a deviation investigation opened in November 2015 were not completed until October 2017, and the CAPA was still open at the time of inspection with no justification for its extension. In addition, no routines were established to gauge the effectiveness of the firm’s CAPAs.
The facility also failed to properly clean equipment and tools to prevent contamination. A suit used by an operator at the facility was not properly evaluated for its potential to spread drug substances and cause cross-contamination. Specifically, the inspector observed its removable strap come in contact with material during the manufacturing process.
In addition, the facility lacked documented procedures for testing materials or recording and storing laboratory data.