# FDA 483 - Germaine Laboratories, Inc - September 27, 2023

Source: https://www.globalkeysolutions.net/records/483/germaine-laboratories-inc/5ef089a8-623e-4364-a201-acd33dead349

> FDA 483 for Germaine Laboratories, Inc on September 27, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Germaine Laboratories, Inc
- Inspection Date: 2023-09-27
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Germaine Laboratories, Inc., a medical device manufacturer in San Antonio, TX, received five observations during an FDA inspection. The firm was cited for deficiencies in process validation approval, lack of established statistical techniques for process control, and inadequate implementation of corrective and preventive action procedures. Additionally, device history records lacked required acceptance documentation, and internal quality audit procedures were not adequately established or followed.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/germaine-laboratories-inc/d26bc41c-a152-4e32-9f6c-8ecbff2364d8

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab