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

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.