# FDA 483 - Reprobiotech Corp - September 05, 2019

Source: https://www.keypedia.com/records/483/reprobiotech-corp/22f3a2cf-8241-4fa0-b224-9f58fee441b0

> FDA 483 for Reprobiotech Corp on September 05, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reprobiotech Corp
- Inspection Date: 2019-09-05
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Reprobiotech Corp in Flushing, NY, a developer and manufacturer of embryo storage containers, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included a lack of established procedures for critical quality activities, inadequate purchasing controls for contract manufactured products, and insufficient documentation for contractor evaluations and agreements. Additionally, the firm failed to develop written procedures for Medical Device Reporting of adverse incidents.

## Related Officers

- [Jacqueline S. Warner](https://www.keypedia.com/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.keypedia.com/companies/reprobiotech-corp/2a7115f6-b546-4451-997a-734406e0c998

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961