# FDA 483 - Neotech Products, LLC - June 09, 2022

Source: https://www.globalkeysolutions.net/records/483/neotech-products-llc/62bcbb88-98aa-42c6-8113-9ddd36d2df36

> FDA 483 for Neotech Products, LLC on June 09, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neotech Products, LLC
- Inspection Date: 2022-06-09
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Neotech Products, LLC, a Class I & II medical device manufacturer in Valencia, CA, was cited for three observations during an FDA inspection. The observations primarily concern inadequate documentation of corrective and preventive actions, insufficient procedures for finished device acceptance, and deficiencies in design verification record-keeping. These issues indicate a need for improved quality system controls and adherence to regulatory requirements.

## Related Officers

- [Kelvin Cheung](https://www.globalkeysolutions.net/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.globalkeysolutions.net/companies/neotech-products-llc/950009ab-4ee8-4640-a72f-3774e3945049

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