# FDA 483 - LIFECYCLE BIOTECHNOLOGIES, LP - June 23, 2023

Source: https://www.keypedia.com/records/483/lifecycle-biotechnologies-lp/28e5f55b-a49c-4af8-81bf-bb743dffd5dd

> FDA 483 for LIFECYCLE BIOTECHNOLOGIES, LP on June 23, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: LIFECYCLE BIOTECHNOLOGIES, LP
- Inspection Date: 2023-06-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: LIFECYCLE BIOTECHNOLOGIES, LP in Cleburne, TX, was cited for significant deficiencies in quality assurance, laboratory controls, and equipment management during an inspection of its PET drug manufacturing facility. Observations included failures to follow written procedures, unsuitable analytical methods, unqualified equipment, and release of out-of-specification product. These issues indicate a lack of robust quality systems that could impact product identity, strength, quality, or purity.

## Related Officers

- [Dorothy P. Kramer](https://www.keypedia.com/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)
- [Oluwasunm Aghahige](https://www.keypedia.com/people/oluwasunm-aghahige/334bb873-fefc-4753-bd65-776ce3424070)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/lifecycle-biotechnologies-lp/2ab92f9d-ae57-426b-bdff-890369cd2535

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