# FDA 483 - Rebel Converting, LLC - February 24, 2025

Source: https://www.keypedia.com/records/483/rebel-converting-llc/90f1cc2b-b727-46b2-a981-9f76fcf618b0

> FDA 483 for Rebel Converting, LLC on February 24, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Rebel Converting, LLC
- Inspection Date: 2025-02-24
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection conducted from February 18-24, 2025, at Rebel Converting LLC revealed significant manufacturing deficiencies in its production of OTC monograph drug products, specifically Benzalkonium Chloride (BZK) wipes. The inspection identified five primary observations, indicating non-compliance with current Good Manufacturing Practices (cGMP) under the Federal Food, Drug, and Cosmetic Act. Key violations included inadequate testing of drug products for identity and strength of active ingredients, leading to the release of numerous batches of BZK wipes below their labeled claim. The company also lacked a proper stability program to support product expiration dates and failed to establish time limits for in-process materials (hold time studies). Furthermore, Rebel Converting LLC did not adequately verify the identity of raw materials, such as glycerin, or test for impurities like DEG and EG. The Quality Control unit exhibited multiple shortcomings, including insufficient manufacturing control limits, absence of USP microbial testing on final products, and a failure to track out-of-specification results or implement an environmental monitoring program. Critical issues with data integrity were noted, such as the use of unprotected Excel spreadsheets that allowed data overwriting and incomplete investigations into product deviations. Rebel Converting LLC is required to implement comprehensive corrective actions to address these systemic issues, ensuring product quality, safety, and compliance with regulatory standards.

## Related Documents

- [483 - 2024-02-24](https://www.keypedia.com/records/483/rebel-converting-llc/ab40cdf2-d4f9-4af0-9829-1418d6c78752)
- [483 - 2025-02-24](https://www.keypedia.com/records/483/rebel-converting-llc/6732755f-b9ac-4de5-b98f-d5f4161ebcdb)

## Related Officers

- [Michael Todd](https://www.keypedia.com/people/michael-todd/d582fb48-2907-430c-b265-ee5eb6770047)
- [Lori B. Wikstrom](https://www.keypedia.com/people/lori-b-wikstrom/19d938f7-4a5d-42b9-b2d1-e92cdb63bb0d)

Company: https://www.keypedia.com/companies/rebel-converting-llc/daddee4d-793b-4bbc-a0af-05ca9de86ca6

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d