# FDA 483 - Glanbia Performance Nutrition (Manufacturing), Inc - June 05, 2025

Source: https://www.keypedia.com/records/483/glanbia-performance-nutrition-manufacturing-inc/8dc24533-5e53-4c56-8e89-72867882ecae

> FDA 483 for Glanbia Performance Nutrition (Manufacturing), Inc on June 05, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glanbia Performance Nutrition (Manufacturing), Inc
- Inspection Date: 2025-06-05
- Product Type: other
- Office Name: Florida District Office
- Summary: During an FDA inspection conducted from June 3-5, 2025, Glanbia Performance Nutrition, Inc., a dietary supplement manufacturer in Sunrise, FL, was cited for several significant observations related to its manufacturing and quality control processes. The inspection, documented in an FDA Form 483, indicated non-compliance with regulatory standards for dietary supplement production.

Key issues included the company's failure to conduct essential identity testing for dietary ingredients, specifically citing Opti-Men Blend and Opti-Women Blend, prior to their use in manufacturing. Additionally, Glanbia Performance Nutrition did not establish complete identity and other necessary specifications for components, such as the Opti-Men Blend. The firm was also observed to lack proper verification of finished dietary supplement specifications for products like Opti-Men Bulk PC Tabs, failing to use scientifically sound methods or adequately document that its process control system ensures consistent product compliance.

A critical finding highlighted that quality control personnel failed to reject batches of dietary supplements that did not meet established specifications. For example, Opti-Women Universal Bulk Caps batches were found to contain levels of Iodine, Molybdenum, Chromium, and Selenium that were outside the company's own specified limits, yet were not rejected. The company is required to implement comprehensive corrective actions to address these deficiencies in ingredient testing, specification establishment, finished product verification, and quality control to ensure adherence to federal food and drug regulations.

## Related Documents

- [483 - 2025-06-05](https://www.keypedia.com/records/483/glanbia-performance-nutrition-manufacturing-inc/d45b3383-533c-4b2c-9091-eefac8f682c5)

## Related Officers

- [Investigator](https://www.keypedia.com/people/meredith-p-soehl/52252b59-8f03-41e4-a86f-b92c98048023)

Company: https://www.keypedia.com/companies/glanbia-performance-nutrition-manufacturing-inc/a31b7b8b-37b6-4882-8bcd-3dcb580c6640

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9