# FDA 483 - Ramco Laboratories, Inc - January 22, 2020

Source: https://www.globalkeysolutions.net/records/483/ramco-laboratories-inc/aece7fae-7baa-4b24-bda2-42e13e3371e1

> FDA 483 for Ramco Laboratories, Inc on January 22, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ramco Laboratories, Inc
- Inspection Date: 2020-01-22
- Product Type: device
- Office Name: Dallas District Office
- Summary: Ramco Laboratories, Inc. in Stafford, TX, an IVD manufacturer, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate device master records, lack of process and stability validations for their IVD devices, and unapproved changes to specifications, methods, and processes. Additionally, the firm's corrective and preventive action procedures were found to be insufficient, leading to uninvestigated recurring product nonconformances.

## Related Officers

- [Jocelyn C. Turner](https://www.globalkeysolutions.net/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.globalkeysolutions.net/companies/ramco-laboratories-inc/2a0439d7-e2af-4627-bd80-6243fc881c96

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9