# FDA 483 - American Herbal Laboratories, Inc - September 10, 2021

Source: https://www.keypedia.com/records/483/american-herbal-laboratories-inc/6b4fa296-13e6-42c4-b0be-424a376f4697

> FDA 483 for American Herbal Laboratories, Inc on September 10, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Herbal Laboratories, Inc
- Inspection Date: 2021-09-10
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of American Herbal Laboratories, Inc. in Rosemead, CA, revealed significant deficiencies in their dietary supplement manufacturing processes. The firm failed to establish and adhere to proper specifications for identity, contamination, and finished product testing for both raw materials and final products. Numerous issues were also identified with their Master Manufacturing Records, including a lack of specific batch sizes, component weights, theoretical yields, and adequate verification procedures, indicating a systemic breakdown in quality control.

## Related Officers

- [investigator](https://www.keypedia.com/people/phal-k-chhun/5b9e07c1-c9cd-457d-b6e3-275bcdca157d)

Company: https://www.keypedia.com/companies/american-herbal-laboratories-inc/5fa0fd71-f4f0-460d-8a6c-dabf4ae83185

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