# FDA 483 - American Spraytech LLC - April 11, 2024

Source: https://www.keypedia.com/records/483/american-spraytech-llc/5ccb97d1-8a02-4e22-af96-b4124877fa36

> FDA 483 for American Spraytech LLC on April 11, 2024. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Spraytech LLC
- Inspection Date: 2024-04-11
- Product Type: devices
- Office Name: Food and Drug Administration
- Summary: An FDA inspection conducted at American Spraytech LLC from April 1, 2024, to April 11, 2024, resulted in the issuance of a Form FDA 483, detailing two significant observations concerning their quality management system. The company, a contract manufacturer, was found to lack adequate procedures for controlling nonconforming product. Specifically, during facility walkthroughs, nonconforming cans and actuators were observed without established processes for their identification, documentation, evaluation, segregation, and disposition during manufacturing. Furthermore, the inspection revealed deficiencies in the firm's corrective and preventive action (CAPA) system. American Spraytech LLC had not adequately established procedures for analyzing quality data to identify causes of nonconforming product or other quality issues. This included a failure to perform adequate analysis for in-process and final nonconformances, and a lack of demonstrated analysis of critical features for products like "Wound Wash Saline." Crucially, five reviewed CAPAs related to "Wound Wash Saline" lacked documented root cause analyses, a requirement specified in their own Corrective Action / Preventive Action SOP. These observations indicate a need for American Spraytech LLC to establish and execute robust quality system processes to ensure compliance with regulatory standards. The firm is responsible for addressing these findings through prompt and effective corrective actions.

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## Related Officers

- [Shelby N. Turner](https://www.keypedia.com/people/shelby-n-turner/77268f33-ae48-4e30-abad-4d79c1077185)

Company: https://www.keypedia.com/companies/american-spraytech-llc/fc33eb75-e75e-42fd-b6a5-a042d486fb23

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516