# FDA 483 - Himalaya Wellness Company - May 24, 2024

Source: https://www.keypedia.com/records/483/himalaya-wellness-company/f475da72-8bf8-43f1-8b5d-8c4036d9ee71

> FDA 483 for Himalaya Wellness Company on May 24, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Himalaya Wellness Company
- Inspection Date: 2024-05-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Himalaya Wellness Company in Bengaluru, India, revealed significant deficiencies in the manufacturing of dietary supplements for export to the United States. The firm failed to ensure that its identity testing methods, specifically thin layer chromatography, were scientifically valid and utilized reliable reference standards. Additionally, the company did not establish adequate strength specifications for either its finished dietary supplements or their herbal components.

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Company: https://www.keypedia.com/companies/himalaya-wellness-company/3f6af3e1-301b-45f7-99b2-b721a90fbff3

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1