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