# FDA 483 - Anesthesia Associates Inc - December 18, 2023

Source: https://www.globalkeysolutions.net/records/483/anesthesia-associates-inc/8275ce54-f10d-4fb1-9925-2c3bd2ea9315

> FDA 483 for Anesthesia Associates Inc on December 18, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Anesthesia Associates Inc
- Inspection Date: 2023-12-18
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Anesthesia Associates Inc. in San Marcos, CA, a medical device manufacturer, revealed significant deficiencies across its quality system. The firm lacked adequate procedures for purchasing, corrective and preventive actions, device history records, complaint handling, acceptance activities, device master records, and design history files. These observations indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.

## Related Documents

- [483 - 2019-03-14](https://www.globalkeysolutions.net/records/483/anesthesia-associates-inc/29756e89-5526-4804-b462-3c6b393c41b1)

## Related Officers

- [Jenny L. Chisem](https://www.globalkeysolutions.net/people/jenny-l-chisem/d9c3fada-4f08-4f1a-9c6c-06a3c521534c)

Company: https://www.globalkeysolutions.net/companies/anesthesia-associates-inc/e8001b50-693e-452c-b95a-ba4d56d5d3aa

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