# FDA 483 - HNC Products Inc. - March 17, 2020

Source: https://www.keypedia.com/records/483/hnc-products-inc/dab75853-be45-4c3b-bece-b7fe0d7b1b4f

> FDA 483 for HNC Products Inc. on March 17, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HNC Products Inc.
- Inspection Date: 2020-03-17
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: HNC Products Inc. in Clinton, IL, a contract cosmetic and drug manufacturer, was inspected and cited for significant deficiencies in its quality control, laboratory controls, and manufacturing processes for OTC sunscreen drug products. The inspection revealed a lack of adequate procedures, incomplete records, and failures in investigation and equipment calibration, indicating a systemic breakdown in GMP compliance.

## Related Documents

- [WARNING_LETTER - 2020-03-17](https://www.keypedia.com/records/warning_letter/hnc-products-inc/77628ba1-1ffd-45fc-accb-f65958c4e4a2)
- [483 - 2021-08-24](https://www.keypedia.com/records/483/hnc-products-inc/0fe63120-ff51-46ba-ae08-a890ce882739)

## Related Officers

- [Constantin Y. Philopoulos](https://www.keypedia.com/people/constantin-y-philopoulos/536d53f5-7699-4b27-8b4b-10280cce9603)
- [Investigator ](https://www.keypedia.com/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)

Company: https://www.keypedia.com/companies/hnc-products-inc/300fb253-ba47-4eae-ba82-7c9b79df0e5b

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669