# FDA 483 - Private Label Partners, Inc. - January 17, 2025

Source: https://www.globalkeysolutions.net/records/483/private-label-partners-inc/69082eb0-302e-4079-b724-9705dda9bc9c

> FDA 483 for Private Label Partners, Inc. on January 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Private Label Partners, Inc.
- Inspection Date: 2025-01-17
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Private Label Partners, Inc., a drug manufacturer in Santa Ana, CA, was inspected by the FDA from January 13-17, 2025. The inspection revealed significant deficiencies across multiple quality systems, including inadequate finished product and component testing, failure to follow stability programs, insufficient investigations into out-of-specification results, and missing batch records. These findings indicate a lack of robust controls to ensure the identity, strength, quality, and purity of drug products.

## Related Documents

- [483 - 2019-09-13](https://www.globalkeysolutions.net/records/483/private-label-partners-inc/a0ecea3d-30da-4fa8-8bd7-52eacfca9c21)

## Related Officers

- [Regulatory Affairs Specialist](https://www.globalkeysolutions.net/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)
- [Lena Nguyen](https://www.globalkeysolutions.net/people/lena-nguyen/99d85719-61c2-40bb-8358-0f3a98747e0d)

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

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b