# FDA 483 - Pinnacle Transplant Technologies, LLC - February 28, 2020

Source: https://www.globalkeysolutions.net/records/483/pinnacle-transplant-technologies-llc/4e434c61-e9f4-422e-9be8-6128b97aa8fb

> FDA 483 for Pinnacle Transplant Technologies, LLC on February 28, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pinnacle Transplant Technologies, LLC
- Inspection Date: 2020-02-28
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Pinnacle Transplant Technologies, LLC in Phoenix, AZ, a tissue processor, was cited for significant deficiencies during an FDA inspection. The firm failed to validate its aseptic and sterilization processes for its human allograft product, PalinGen Flow, and lacked established procedures for investigating microbial contamination and sterility failures. Additionally, the company did not thoroughly investigate failed batches or environmental microbial positives, indicating a severe lack of quality control in preventing contamination.

## Related Documents

- [483 - 2022-08-29](https://www.globalkeysolutions.net/records/483/pinnacle-transplant-technologies-llc/e37e0e10-77ad-4272-9638-6f9aba6760e7)
- [WARNING_LETTER - 2022-08-29](https://www.globalkeysolutions.net/records/warning_letter/pinnacle-transplant-technologies-llc/ced9ff31-bef5-42ed-97bf-c8400b27e13f)

## Related Officers

- [Garrad R. Poole](https://www.globalkeysolutions.net/people/garrad-r-poole/7fc97953-367e-459b-905d-25efe6ec39d2)
- [issuing_officer](https://www.globalkeysolutions.net/people/matthew-j-gretkierewicz/d2b43230-5324-44e0-9cd0-7e40464bf5b0)

Company: https://www.globalkeysolutions.net/companies/pinnacle-transplant-technologies-llc/d8cd8d1a-c35f-45cd-bf64-c8fee520dae5

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