# FDA 483 - Hyland's Consumer Health Inc. - November 29, 2022

Source: https://www.keypedia.com/records/483/hylands-consumer-health-inc/d149bac5-4f2d-4e7b-a592-6b7d7b71f471

> FDA 483 for Hyland's Consumer Health Inc. on November 29, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hyland's Consumer Health Inc.
- Inspection Date: 2022-11-29
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Hyland's Consumer Health Inc. in Los Angeles, CA, was inspected by the FDA, resulting in five observations related to quality system, production system, and laboratory system deficiencies. The inspection revealed issues with investigation records, process validation, complaint handling procedures, master production records, and verification of testing methods, indicating significant concerns across multiple aspects of their drug manufacturing operations.

## Related Documents

- [FDA_REQUESTED_RECALL_LETTER - 2016-09-20](https://www.keypedia.com/records/fda_requested_recall_letter/hylands-consumer-health-inc/128dada2-533f-445a-a8bb-97416b3cb8de)

## Related Officers

- [https://www.fda.gov/media/120628/download](https://www.keypedia.com/people/santiago-gallardo-johnson/f5086b0c-c8fc-44dd-8d12-6506b9dd313f)

Company: https://www.keypedia.com/companies/hylands-consumer-health-inc/c2b2c0e5-bc16-4037-806c-5eb82f3361d2

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