# FDA 483 - Olds Softgels, Inc. - September 18, 2017

Source: https://www.keypedia.com/records/483/olds-softgels-inc/da1ad7d7-b304-4768-81a3-8fe0ee27c8e2

> FDA 483 for Olds Softgels, Inc. on September 18, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Olds Softgels, Inc.
- Inspection Date: 2017-09-18
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Olds Softgels, Inc. in Olds, Alberta, was inspected regarding its manufacturing of OTC human drug products. The inspection revealed significant deficiencies in process validation, equipment maintenance, stability testing, and quality control procedures. These issues indicate a lack of assurance in product quality and potential contamination risks.

## Related Officers

- [Jose A. Cruz Gonzalez](https://www.keypedia.com/people/jose-a-cruz-gonzalez/a005cff1-0a90-4396-82c4-de4b0a579374)

Company: https://www.keypedia.com/companies/olds-softgels-inc/2d9e5f1f-22df-4b16-80ce-3efdd5f1b65c

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321