# Carrashield Labs Inc. – FDA 483, Apr 29, 2026

Source: https://www.keypedia.com/records/483/carrashield-labs-inc/97705009-8eba-4d0d-90af-1beacac386fa

> FDA 483 for Carrashield Labs Inc. on April 29, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Carrashield Labs Inc.
- Inspection Date: 2026-04-29
- Product Type: device
- Office Name: Florida District Office
- Summary: An FDA inspection of Carrashield, Labs Inc. in Saint Petersburg, FL, revealed three significant observations related to their quality system for medical devices. The firm failed to adequately implement risk management outputs into design inputs, did not perform or document design verification for labeling changes, and lacked unique device identifiers (UDI) on their Divine 9 personal lubricant device labels. These issues indicate deficiencies in design control and labeling compliance.

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Company: https://www.keypedia.com/companies/carrashield-labs-inc/1a41fb73-9f06-4bcc-baf1-1098fa2df1eb

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9