# FDA 483 - R & B Medical Group Inc. - September 25, 2019

Source: https://www.keypedia.com/records/483/r-b-medical-group-inc/bcb46b69-193a-4975-89b9-85d304345337

> FDA 483 for R & B Medical Group Inc. on September 25, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: R & B Medical Group Inc.
- Inspection Date: 2019-09-25
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: B C Medical Group Inc. in Van Nuys, CA, an RCDAD Testing Laboratory, was cited for significant deficiencies in its quality program and testing procedures during an FDA inspection. Observations included a lack of a quality program to manage deviations, absence of written procedures for HCT/P manufacturing steps, and failure to follow manufacturer's instructions for communicable disease testing. Additionally, the firm's record-keeping and personnel oversight were found to be inadequate, with incomplete and unreviewed testing documents and insufficient staff for proper supervision.

## Related Documents

- [WARNING_LETTER - 2019-09-25](https://www.keypedia.com/records/warning_letter/r-b-medical-group-inc/ebd19f02-5a1a-4dee-bcb1-dbab0a004132)

## Related Officers

- [Laurissa S. Flowers](https://www.keypedia.com/people/laurissa-s-flowers/27453525-c2fc-4a05-9cdc-7a1ed884304f)
- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/r-b-medical-group-inc/cfc94659-cdd7-4462-af33-36be815fbee0

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