# FDA 483 - Vet Cellect Bio Products, LLC - July 09, 2021

Source: https://www.globalkeysolutions.net/records/483/vet-cellect-bio-products-llc/bc10d84a-2bc7-4b92-9170-97c0b468d081

> FDA 483 for Vet Cellect Bio Products, LLC on July 09, 2021. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vet Cellect Bio Products, LLC
- Inspection Date: 2021-07-09
- Product Type: veterinary
- Office Name: New Jersey District Office
- Summary: Vet Collect Bio Products, LLC, an own label distributor of veterinary drug products in Manalapan, NJ, was cited for distributing an unapproved veterinary drug product, ExCellR8 Topical Cream, despite multiple notifications to cease marketing. The firm also failed to provide quality oversight for the contract manufacturing of this product, lacking analytical data and quality agreements with suppliers. These observations indicate significant deficiencies in regulatory compliance and quality control for their distributed products.

## Related Documents

- [WARNING_LETTER - Unknown Date](https://www.globalkeysolutions.net/records/warning_letter/vet-cellect-bio-products-llc/f98c7cb4-9a16-4506-9328-1f33c45d980a)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/jay-b-shah/c437fff9-807e-4dea-80c0-8f77850db6f8)
- [Odara Eleweke](https://www.globalkeysolutions.net/people/odara-eleweke/2ade3074-cf90-4897-a384-9af71f42db5d)
- [Russell Ginyion](https://www.globalkeysolutions.net/people/russell-ginyion/abadc991-b77c-422f-b305-1d99ce32078d)

Company: https://www.globalkeysolutions.net/companies/vet-cellect-bio-products-llc/819bfe1e-de46-4f18-83fb-4f3b05d398df

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248