# FDA 483 - Sacks Holdings, Inc. - March 29, 2024

Source: https://www.globalkeysolutions.net/records/483/sacks-holdings-inc/9d375a00-54d5-4865-91d9-3e8f18b02c11

> FDA 483 for Sacks Holdings, Inc. on March 29, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sacks Holdings, Inc.
- Inspection Date: 2024-03-29
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Sacks Holdings, Inc., a specification developer in San Diego, CA, received an FDA Form 483 citing significant quality system deficiencies related to its Class II Contact Lens Cases. The inspection revealed inadequate maintenance of device history records, a lack of established procedures for finished device acceptance, and failure to establish records for acceptable suppliers. These observations highlight a lack of control over critical manufacturing, release, and supplier management processes.

## Related Officers

- [Jenny L. Chisem](https://www.globalkeysolutions.net/people/jenny-l-chisem/d9c3fada-4f08-4f1a-9c6c-06a3c521534c)
- [Linda Galindo](https://www.globalkeysolutions.net/people/linda-galindo/6bc29df6-192b-4d89-92ae-20cc1660d9ad)

Company: https://www.globalkeysolutions.net/companies/sacks-holdings-inc/935e65b8-629a-4c13-8824-4d3ad41d0636

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