# FDA 483 - Kimera Labs Inc - July 21, 2022

Source: https://www.keypedia.com/records/483/kimera-labs-inc/e5a90205-5c57-4433-aad3-cf435099dddf

> FDA 483 for Kimera Labs Inc on July 21, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kimera Labs Inc
- Inspection Date: 2022-07-21
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Kimera Labs Inc. received a Form 483 citing numerous deficiencies in its manufacturing and quality control processes for biological drug products like XoGlo, XoGlo Pro, and Amnio 2X. The observations highlight a critical lack of validation for aseptic processes, cleaning, equipment, and sterility testing, alongside inadequate procedures for environmental monitoring, investigations, and material management. These issues indicate a systemic failure to ensure the identity, strength, quality, and purity of its sterile drug products.

## Related Officers

- [Cody D Riessan](https://www.keypedia.com/people/cody-d-riessan/00bdb425-0d15-44e0-a524-853a7543a2d3)
- [Sergio E. Delgado](https://www.keypedia.com/people/sergio-e-delgado/5edfee62-05aa-44aa-9161-def8f31d3ea2)
- [Ivan E. Reyes](https://www.keypedia.com/people/ivan-e-reyes/69bac3eb-f63c-45f0-8420-85a7e06b884a)
- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)

Company: https://www.keypedia.com/companies/kimera-labs-inc/8d487bd0-8c45-4aef-84f0-0aae77b0598f

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6