# FDA 483 - BAPS Swaminarayan Herbal Care, A Unit of Divine Energy - August 17, 2019

Source: https://www.globalkeysolutions.net/records/483/baps-swaminarayan-herbal-care-a-unit-of-divine-energy/eae4e65c-5684-4766-ad99-666a57713a6e

> FDA 483 for BAPS Swaminarayan Herbal Care, A Unit of Divine Energy on August 17, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BAPS Swaminarayan Herbal Care, A Unit of Divine Energy
- Inspection Date: 2019-08-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspected BAPS Swaminarayan Herbal Care, a manufacturer of OTC drug products, and found significant deficiencies. The firm lacked written procedures for quality control, supplier qualification, process and equipment validation, and material sampling. Additionally, issues were noted with personnel training, laboratory controls, batch record documentation, and annual product reviews, indicating a broad failure to adhere to cGMP requirements.

## Related Officers

- [Food and Nutration Service ](https://www.globalkeysolutions.net/people/farhana-khan/2388f1b3-b96c-4ae9-a520-d469ef762ce9)

Company: https://www.globalkeysolutions.net/companies/baps-swaminarayan-herbal-care-a-unit-of-divine-energy/77532b27-3a70-4e1e-a401-4b4ca856ae4b

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