# FDA 483 - CerBurg Products Ltd. - September 17, 2021

Source: https://www.keypedia.com/records/483/cerburg-products-ltd/07a0c66f-91fa-4f60-ad92-1f8d0feb0714

> FDA 483 for CerBurg Products Ltd. on September 17, 2021. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: CerBurg Products Ltd.
- Inspection Date: 2021-09-17
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Cerburg Products Ltd. in South Daytona, FL, an own label distributor of ProFibe dietary supplement, was cited for significant deficiencies in its quality control operations. The inspection revealed a lack of written procedures for critical processes such as material review, disposition decisions, and product complaint investigations. Additionally, the firm failed to verify finished product specifications and provide stability data to support product expiration dates, with some issues being repeat observations from a previous inspection.

## Related Documents

- [EIR - 2021-09-17](https://www.keypedia.com/records/eir/cerburg-products-ltd/0c144aa4-7ecf-4278-a5d3-1c10be2ca439)

## Related Officers

- [investigator](https://www.keypedia.com/people/robert-w-calais/394ed883-caf9-43d2-9dd2-dab1d14f1a00)

Company: https://www.keypedia.com/companies/cerburg-products-ltd/7c99e473-dbaf-420f-94c3-74850971eead

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6