# FDA 483 - Purolea Cosmetics Lab - October 30, 2025

Source: https://www.globalkeysolutions.net/records/483/purolea-cosmetics-lab/e05c488f-106d-4b47-94c8-4ebb94b8dcfa

> FDA 483 for Purolea Cosmetics Lab on October 30, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Purolea Cosmetics Lab
- Inspection Date: 2025-10-30
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: Purolea Cosmetics Lab, a homeopathic drug manufacturer in Livonia, MI, was cited for significant deficiencies in its manufacturing processes and quality control. The inspection revealed a lack of proper batch records, inadequate product testing, insufficient component identity testing, and an absence of written procedures for quality control, stability, and process validation. These issues indicate a systemic failure to adhere to current Good Manufacturing Practices (cGMPs) for drug products.

## Related Documents

- [WARNING_LETTER - 2025-10-30](https://www.globalkeysolutions.net/records/warning_letter/purolea-cosmetics-lab/795fcf6d-f554-4956-a065-ba6f16fcaa07)

## Related Officers

- [Melissa M. Steiger](https://www.globalkeysolutions.net/people/melissa-m-steiger/513a7364-15df-474f-8a8a-b5c4ff1cf59f)

Company: https://www.globalkeysolutions.net/companies/purolea-cosmetics-lab/a2662a80-cd8c-4da0-bd8d-6cd4ea6079c6

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03