FDA 483 - Private Label Partners, Inc. - September 13, 2019

An FDA inspection of Private Label Partners, Inc. in Santa Ana, CA, revealed multiple significant deficiencies across various operational areas. The firm failed to conduct proper investigations into out-of-specification results and lacked adequate equipment qualification and maintenance records. Additionally, issues were identified with facility sanitation, pest control, and the segregation and storage of materials, indicating a general lack of adherence to good manufacturing practices.