# FDA 483 - ARMM Inc - April 16, 2019

Source: https://www.keypedia.com/records/483/armm-inc/770acc10-7cb3-40f2-acf2-40627d330804

> FDA 483 for ARMM Inc on April 16, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARMM Inc
- Inspection Date: 2019-04-16
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: ARMM Inc, a medical device manufacturer in Huntington Beach, CA, was inspected by the FDA. The inspection revealed inadequate documentation for a validated process, specifically concerning sterile barrier integrity for ARMM Drain Catheters. This issue was noted as a repeat observation from a previous inspection.

## Related Officers

- [investigator](https://www.keypedia.com/people/juanita-banuelos/b8b581ef-b9f3-4d77-a9fa-691223dbb7f4)

Company: https://www.keypedia.com/companies/armm-inc/78815c8e-a19c-4e1b-9e21-626871a9b25b

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6