San Diego City Wire

There were five companies in cities associated with San Diego County that received FDA citations as a result of five inspections conducted in the county in July, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 400% increase over the number of companies cited in the previous month.

The citations in the county include:

• Quality audits were not performed at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures.
• Procedures for design transfer have not been adequately established.
• Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.

Most of the companies cited were involved in the Food and Cosmetics sector.

All of the companies cited should take voluntary actions to correct their managing operations.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Company Name	Area of Business	Inspection Date	Issue Cited
CMR Naviscan Corporation	Devices	07/18/2024	Quality Audits - defined intervals
CMR Naviscan Corporation	Devices	07/18/2024	Design transfer - Lack of or inadequate procedures
CMR Naviscan Corporation	Devices	07/18/2024	Lack of or inadequate complaint procedures
California Splendor, Inc.	Food and Cosmetics	07/11/2024	Sanitation of food-contact surfaces - Frequency
Chula Seafood	Food and Cosmetics	07/31/2024	Critical limits
Chula Seafood	Food and Cosmetics	07/31/2024	Calibration - adequacy
Chula Seafood	Food and Cosmetics	07/31/2024	Monitoring record review adequacy
Doctor's Signature Sales and Marketing International Corporation	Food and Cosmetics	07/10/2024	Specifications - component identity
Doctor's Signature Sales and Marketing International Corporation	Food and Cosmetics	07/10/2024	Specifications-component purity, strength, composition
Doctor's Signature Sales and Marketing International Corporation	Food and Cosmetics	07/10/2024	Specifications - identity, purity, strength, composition
Doctor's Signature Sales and Marketing International Corporation	Food and Cosmetics	07/10/2024	Master manufacturing record - specifications; quality
Doctor's Signature Sales and Marketing International Corporation	Food and Cosmetics	07/10/2024	Batch record - complete
El Super Leon Ponchin Snacks, Inc.	Food and Cosmetics	07/25/2024	Sanitary operations - Plant maintenance
El Super Leon Ponchin Snacks, Inc.	Food and Cosmetics	07/25/2024	Food safety plan