# FDA 483 - Jeffrey M. Steinberg MD, Inc., A Professional Medical Corporation - May 16, 2023

Source: https://www.globalkeysolutions.net/records/483/jeffrey-m-steinberg-md-inc-a-professional-medical-corporation/06f5a9ee-bc84-4bd6-8005-5cb08006cd3e

> FDA 483 for Jeffrey M. Steinberg MD, Inc., A Professional Medical Corporation on May 16, 2023. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Jeffrey M. Steinberg MD, Inc., A Professional Medical Corporation
- Inspection Date: 2023-05-16
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Jeffrey M. Steinberg MD, Inc. dba The Fertility Institutes, a reproductive fertility center in Encino, CA, was cited for six observations related to donor screening, HCT/P labeling, and donor eligibility determinations. The inspection revealed significant deficiencies in screening for communicable diseases, inadequate labeling of HCT/Ps from both eligible and ineligible donors, and failures to properly document donor eligibility. These issues indicate a moderate level of non-compliance with regulations concerning human cells, tissues, and cellular and tissue-based products (HCT/Ps).

## Related Officers

- [Tania Y. Hall](https://www.globalkeysolutions.net/people/tania-y-hall/94f342b2-a5f3-4ff1-ae5a-7f75fefe2214)
- [Celeta S. Coves](https://www.globalkeysolutions.net/people/celeta-s-coves/d0f63577-a6e4-4872-b06c-a024188a04ba)

Company: https://www.globalkeysolutions.net/companies/jeffrey-m-steinberg-md-inc-a-professional-medical-corporation/45cf7e4a-61ba-48bd-929d-5730f2c0bd26

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