# FDA 483 - Arcamed LLC - September 21, 2023

Source: https://www.keypedia.com/records/483/arcamed-llc/5a36693f-f14d-448e-914c-ba65b8ee3e06

> FDA 483 for Arcamed LLC on September 21, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arcamed LLC
- Inspection Date: 2023-09-21
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Arcamed LLC, a manufacturer in Indianapolis, IN, was inspected by the FDA and received a Form 483. The inspection identified deficiencies in the firm's quality management system, specifically regarding procedures for controlling nonconforming product, corrective and preventive actions (CAPA), and internal quality audits. These observations highlight a lack of adequate documentation and verification processes within their quality system.

## Related Officers

- [Debara R. Reese](https://www.keypedia.com/people/debara-r-reese/277a8fbb-ba4d-4402-be08-16d7977685db)

Company: https://www.keypedia.com/companies/arcamed-llc/bca33d7b-1502-4344-82ba-2e4c6f6fb6b7

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0