Calvin Scott & Company, Inc.June 19, 2023

FDA 483 - Calvin Scott & Company, Inc. - June 19, 2023

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Record Details

Calvin Scott & Company, Inc. in Albuquerque, NM, a repackager and relabeler, received a Form 483 with five observations. The inspection revealed significant deficiencies in quality unit responsibilities, annual product review procedures, employee cGMP training, and equipment maintenance and qualification. Several observations were repeats from previous inspections, indicating persistent issues.

Company: Calvin Scott & Company, Inc.
Inspection Date: June 19, 2023
Product Type: Drugs
Office: Denver District Office
Person: Cecilia H. Kieu

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ID · 4a36bfb4-17cc-4b1f-bec6-e2842ad360b5