# FDA 483 - Texas Injection Molding, LLC - March 21, 2024

Source: https://www.keypedia.com/records/483/texas-injection-molding-llc/061b230e-934c-40d1-b72f-a1a4c2a7a84c

> FDA 483 for Texas Injection Molding, LLC on March 21, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Texas Injection Molding, LLC
- Inspection Date: 2024-03-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Texas Injection Molding, LLC, a medical device contract manufacturer in Houston, received a Form FDA-483 following an inspection. The observations primarily concern deficiencies in process validation for their blow molding operations, inadequate establishment and execution of equipment preventive maintenance, and a lack of a comprehensive Device History Record procedure for medical device lots. These issues indicate significant gaps in their quality system.

## Related Officers

- [Ellen J. Tave](https://www.keypedia.com/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.keypedia.com/companies/texas-injection-molding-llc/609fc551-b615-40ad-a276-7c6d788d853d

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