# FDA 483 - EzriCare, LLC. - March 21, 2023

Source: https://www.keypedia.com/records/483/ezricare-llc/566e0907-3d6d-4df0-b150-56bdc2d4ddd8

> FDA 483 for EzriCare, LLC. on March 21, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: EzriCare, LLC.
- Inspection Date: 2023-03-21
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: EzriCare, LLC, an own-label distributor in Lakewood, NJ, was cited for significant deficiencies in its quality control unit and oversight of contract manufacturing organizations (CMOs). The inspection revealed a complete absence of a quality control unit, lack of written procedures for critical quality events, and inadequate controls for product specifications and complaint handling. These issues indicate a severe lack of control over the quality and purity of its distributed sterile and non-sterile OTC drug products.

## Related Officers

- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)
- [Investigator](https://www.keypedia.com/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

Company: https://www.keypedia.com/companies/ezricare-llc/475b0096-bb9e-4059-869b-9f91ea1c8e24

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