# FDA 483 - Lifecycle Biotechnologies, LP - January 24, 2022

Source: https://www.keypedia.com/records/483/lifecycle-biotechnologies-lp/fb675c25-f15b-42e8-b987-9a8da125cd8d

> FDA 483 for Lifecycle Biotechnologies, LP on January 24, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lifecycle Biotechnologies, LP
- Inspection Date: 2022-01-24
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Lifecycle Biotechnologies, LP, a drug component manufacturer in Loveland, CO, was inspected by the FDA from January 24-28, 2022. The inspection revealed significant deficiencies in manufacturing controls, facility maintenance, and quality unit oversight. Key issues included inadequate yield determination, poor facility repair, and failures in production record review and training documentation.

## Related Officers

- [Consumer Safety Officer (Drug Specialist)](https://www.keypedia.com/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

Company: https://www.keypedia.com/companies/lifecycle-biotechnologies-lp/1fbb3029-b392-4578-bb22-1f78c7d4749d

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face