# FDA 483 - Viking Rubber Products Inc. - April 29, 2019

Source: https://www.keypedia.com/records/483/viking-rubber-products-inc/15c5b3b6-9985-4690-a681-5365d50540f1

> FDA 483 for Viking Rubber Products Inc. on April 29, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Viking Rubber Products Inc.
- Inspection Date: 2019-04-29
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Viking Rubber Products Inc., a medical device manufacturer in San Clemente, CA, identified three significant observations. The firm was cited for deficiencies in device history records not aligning with device master records, a lack of documented process validation activities for manufacturing, and inadequate procedures for finished device acceptance, including issues with inspection records and quantity tracking.

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Company: https://www.keypedia.com/companies/viking-rubber-products-inc/45d90f34-30b4-4ff5-a5e5-c7a5feca817c

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