# FDA 483 - Reproductive Services Of Indiana, Inc - January 20, 2023

Source: https://www.globalkeysolutions.net/records/483/reproductive-services-of-indiana-inc/26e04de9-b346-44d7-9e5b-0881ac2137ef

> FDA 483 for Reproductive Services Of Indiana, Inc on January 20, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reproductive Services Of Indiana, Inc
- Inspection Date: 2023-01-20
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Reproductive Services Of Indiana, Inc. in Carmel, IN, a reproductive facility, was inspected by the FDA. The inspection revealed that records for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) included the first names of anonymous oocyte donors. This indicates a lapse in maintaining donor anonymity within the firm's record-keeping practices.

## Related Officers

- [Lesley Mae P. Lutao](https://www.globalkeysolutions.net/people/lesley-mae-p-lutao/bfdcc755-28e5-4caf-91f9-b9579df4731e)
- [investigator](https://www.globalkeysolutions.net/people/maira-p-brading/892072f4-e584-48d1-890c-e0a47dfbdffa)

Company: https://www.globalkeysolutions.net/companies/reproductive-services-of-indiana-inc/cd3f5497-e0ca-4d55-9ddb-e7ea23b0ac8d

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0