# FDA 483 - UCLA Biomedical Cyclotron - July 31, 2020

Source: https://www.globalkeysolutions.net/records/483/ucla-biomedical-cyclotron/65378da1-6811-4720-b6c1-047fa7d0879d

> FDA 483 for UCLA Biomedical Cyclotron on July 31, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: UCLA Biomedical Cyclotron
- Inspection Date: 2020-07-31
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: UCLA Biomedical Cyclotron, a PET drug manufacturer in Los Angeles, CA, was cited for significant deficiencies across its quality and laboratory control systems during an FDA inspection. Observations included failures in equipment qualification, analytical method validation, record-keeping, and quality assurance procedures, with one observation being a repeat from a previous inspection. These issues indicate a lack of robust controls necessary to ensure the quality and purity of PET drug products.

## Related Documents

- [483 - 2025-07-31](https://www.globalkeysolutions.net/records/483/ucla-biomedical-cyclotron/3eb814fe-3b8c-4da9-adfc-f9e4b47ec923)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [SVP Consulting & Operations](https://www.globalkeysolutions.net/people/linda-f-murphy/a8b9737f-d5f4-4a36-8684-2fb050d008f2)

Company: https://www.globalkeysolutions.net/companies/ucla-biomedical-cyclotron/c81bfa21-90ca-4cbb-b13f-8158b4bcaa44

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