# FDA 483 - Highland Industries,Inc. - July 25, 2019

Source: https://www.keypedia.com/records/483/highland-industriesinc/4c06d4de-119d-45ef-b025-694cc36583e1

> FDA 483 for Highland Industries,Inc. on July 25, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Highland Industries,Inc.
- Inspection Date: 2019-07-25
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Highland Industries, Inc. in Cheraw, SC, a contract manufacturer of medical devices, was cited with seven observations during an FDA inspection. The inspection revealed significant deficiencies across its quality system, particularly concerning process validation, documentation, device acceptance procedures, sampling plans, device history records, equipment maintenance, and the overall quality plan. These issues indicate a lack of adequate controls to ensure medical devices are manufactured according to specifications and regulatory requirements.

## Related Officers

- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.keypedia.com/companies/highland-industriesinc/3c49373e-4354-4687-a7a0-8e8917ac6374

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7