# FDA 483 - PLZ Corp - January 15, 2025

Source: https://www.keypedia.com/records/483/plz-corp/92cf8626-b5cb-4623-bc3a-b76eb2640ec6

> FDA 483 for PLZ Corp on January 15, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PLZ Corp
- Inspection Date: 2025-01-15
- Product Type: drugs
- Summary: During an FDA inspection conducted from January 6 to January 15, 2025, PLZ Corp, a manufacturer located in Fall River, MA, received an FDA Form 483 citing significant observations regarding its operational controls. The inspection revealed that the company lacked established and followed written procedures for the cleaning and maintenance of equipment used in the manufacturing of drug products, specifically for sunscreen and hand sanitizer. A key issue highlighted was the absence of documented cleaning validation for equipment used in repackaging sunscreen, with several lots still available on the U.S. market. Additionally, PLZ Corp failed to perform periodic verification of its validated cleaning procedures for hand sanitizer manufacturing equipment, which is also utilized for non-OTC products. This particular observation concerning cleaning procedures was a repeat finding from a 2019 inspection. Furthermore, the inspection identified that the company failed to establish written procedures for production and process controls to ensure drug products meet identity, strength, purity, and quality standards. Specifically, the repackaging process for sunscreen lacked validation, impacting numerous distributed units. These observations indicate non-compliance with the Federal Food, Drug, and Cosmetic Act and associated Good Manufacturing Practices. PLZ Corp is expected to implement prompt corrective actions to address these deficiencies and ensure regulatory compliance.

## Related Documents

- [483 - 2025-01-15](https://www.keypedia.com/records/483/plz-corp/7209c4c7-7b3e-4562-8911-2b4e5d0c8d67)

## Related Officers

- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [Ogechi C. Nna](https://www.keypedia.com/people/ogechi-c-nna/59452184-8197-4ba6-bf1d-78a7e003ef2c)
- [Plant Manager](https://www.keypedia.com/people/roque-disla/f3b205ba-e368-4c8e-ba85-65e7d688e9e4)

Company: https://www.keypedia.com/companies/plz-corp/acd906c8-50bb-4cf2-a142-ce56fed0a7d8