# FDA 483 - Bernz Medical Sales LLC - March 11, 2019

Source: https://www.globalkeysolutions.net/records/483/bernz-medical-sales-llc/b405e0e3-74e8-4580-a36f-94d42d687a8c

> FDA 483 for Bernz Medical Sales LLC on March 11, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bernz Medical Sales LLC
- Inspection Date: 2019-03-11
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Bern Medical Sales LLC in Ewa Beach, HI, an HCT/P Distributor, revealed two significant observations. The firm failed to establish and document procedures for the receipt, shipment, and distribution of HCT/Ps, and also lacked written procedures for the review, evaluation, documentation, and investigation of complaints related to core CGTP requirements. These issues indicate a lack of fundamental quality system controls.

## Related Officers

- [Lewis K. Antwi](https://www.globalkeysolutions.net/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

Company: https://www.globalkeysolutions.net/companies/bernz-medical-sales-llc/e7c4f49a-d0e1-4686-b02b-f1793a39b7b3

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