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

Source: https://www.globalkeysolutions.net/records/483/private-label-partners-inc/a0ecea3d-30da-4fa8-8bd7-52eacfca9c21

> FDA 483 for Private Label Partners, Inc. on September 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Private Label Partners, Inc.
- Inspection Date: 2019-09-13
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Documents

- [483 - 2025-01-17](https://www.globalkeysolutions.net/records/483/private-label-partners-inc/69082eb0-302e-4079-b724-9705dda9bc9c)

## Related Officers

- [Alan L. Truong](https://www.globalkeysolutions.net/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)

Company: https://www.globalkeysolutions.net/companies/private-label-partners-inc/3efeb4e0-39f6-4018-8698-4a7cb60a7eb6

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6