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

**FDA 483 Summary: Private Label Partners, Inc.**

**Inspection Dates:** January 13-17, 2025 **Company:** Private Label Partners, Inc. **Location:** Santa Ana, CA **Type of Establishment:** Drug Manufacturer

**Main Violations/Issues:**

1. **Laboratory System Deficiencies:** The firm failed to perform necessary finished product testing, including microbiological contamination and assay testing, before releasing drug products. No established specifications were available for products containing Benzalkonium Chloride, which are indicated for antibacterial and antifungal purposes.

2. **Stability Testing Non-compliance:** The company did not adhere to its written stability testing procedures, failing to conduct stability studies to support the expiration dates of its products. This includes a shampoo product released without stability data, which was later recalled.

3. **Inadequate Laboratory Controls:** The firm lacked scientifically sound test procedures to ensure products meet standards of identity, strength, quality, and purity. Specifically, representative sampling and testing results were averaged without proper investigation into out-of-specification results.

**Regulatory Framework:** The observations are based on FDA regulations requiring drug manufacturers to ensure product safety, efficacy, and quality through rigorous testing and stability studies.

**Required Actions:** Private Label Partners, Inc. must implement corrective actions to address the deficiencies noted, including establishing comprehensive testing protocols and conducting stability studies to validate product expiration dates. The firm should engage with the FDA to discuss objections or corrective measures and ensure compliance with regulatory standards.