# FDA 483 - The Mentholatum Company - June 17, 2021

Source: https://www.globalkeysolutions.net/records/483/the-mentholatum-company/fd2a2e74-28ba-405b-8c31-9280b8195291

> FDA 483 for The Mentholatum Company on June 17, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Mentholatum Company
- Inspection Date: 2021-06-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of The Mentholatum Company in Orchard Park, NY, from June 15-17, 2021, revealed significant deficiencies in manufacturing practices. Observations included failures to follow written procedures for raw material testing, inadequate cleaning and maintenance of equipment, and plumbing defects posing contamination risks. Additionally, the firm was cited for a repeat deficiency regarding the delayed submission of an adverse event report for a nonprescription drug.

## Related Officers

- [Johnna L. Bleem](https://www.globalkeysolutions.net/people/johnna-l-bleem/3fe669bf-e354-4cdc-9337-d5ceb23f1c9f)

Company: https://www.globalkeysolutions.net/companies/the-mentholatum-company/b6fe9a36-3f40-411d-82b1-1c00b610492f

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961