# FDA 483 - Tissue Transplant Technology, Ltd. - February 18, 2022

Source: https://www.globalkeysolutions.net/records/483/tissue-transplant-technology-ltd/fe098597-2a81-48b1-aad6-a3810c0ca577

> FDA 483 for Tissue Transplant Technology, Ltd. on February 18, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tissue Transplant Technology, Ltd.
- Inspection Date: 2022-02-18
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Tissue Transplant Technology, Ltd. d/b/a Bone Bank Allografts in San Antonio, TX, an HCT/P manufacturer, was cited for significant deficiencies in its manufacturing processes for human amniotic fluid products. Observations included a lack of validated production controls, inadequate investigation of an adverse event complaint, and failure to establish expiration dates with appropriate stability data. Additionally, the firm failed to ensure components were tested and released by quality control before use.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)
- [investigator](https://www.globalkeysolutions.net/people/maira-p-brading/892072f4-e584-48d1-890c-e0a47dfbdffa)

Company: https://www.globalkeysolutions.net/companies/tissue-transplant-technology-ltd/2180844e-0a1f-43c4-85d6-7b9973ddf38c

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