# FDA 483 - Vacumed, Div of Vacumetrics Inc - February 21, 2020

Source: https://www.globalkeysolutions.net/records/483/vacumed-div-of-vacumetrics-inc/1abff1e1-9cef-44a9-b11f-2c47ceea79a7

> FDA 483 for Vacumed, Div of Vacumetrics Inc on February 21, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vacumed, Div of Vacumetrics Inc
- Inspection Date: 2020-02-21
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Vacumed, Div of Vacumetrics Inc, a Class II medical device manufacturer in Ventura, CA, revealed two significant observations. The firm was cited for failing to adequately maintain records of changes to documents, specifically Device Master Records. Additionally, procedures for corrective and preventive actions were found to be incomplete and not consistently followed.

## Related Documents

- [483 - 2023-09-13](https://www.globalkeysolutions.net/records/483/vacumed-div-of-vacumetrics-inc/7ba400c0-6e19-45b7-b6a6-e5eda5f1d1af)

## Related Officers

- [Kelvin Cheung](https://www.globalkeysolutions.net/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.globalkeysolutions.net/companies/vacumed-div-of-vacumetrics-inc/638961bb-c181-4869-9ea6-44c4048e7a98

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