# FDA 483 - Skye Biologics Holdings LLC - December 09, 2022

Source: https://www.globalkeysolutions.net/records/483/skye-biologics-holdings-llc/b3c215ef-c4dc-43e3-aacb-908e1febef7d

> FDA 483 for Skye Biologics Holdings LLC on December 09, 2022. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Skye Biologics Holdings LLC
- Inspection Date: 2022-12-09
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Skye Biologics Holdings LLC in El Segundo, CA, was inspected and received a Form FDA 483 with seven observations related to significant deficiencies in their manufacturing and quality control systems for biological flowable allograft products. Key issues include lack of process validation, inadequate laboratory controls and environmental monitoring, absence of endotoxin testing and stability studies, and poor batch record documentation and component identity verification. These findings indicate a serious lack of adherence to GMP requirements, potentially impacting product quality and sterility.

## Related Documents

- [WARNING_LETTER - 2022-12-09](https://www.globalkeysolutions.net/records/warning_letter/skye-biologics-holdings-llc/578cd93e-bb5c-407b-ba72-4a439e567fb3)

## Related Officers

- [Garrad R. Poole](https://www.globalkeysolutions.net/people/garrad-r-poole/7fc97953-367e-459b-905d-25efe6ec39d2)
- [investigator](https://www.globalkeysolutions.net/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)

Company: https://www.globalkeysolutions.net/companies/skye-biologics-holdings-llc/955a9fe7-05a2-4d51-b376-f37b83dd7928

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