# FDA 483 - Vilvet Pharmaceuticals Inc. - June 27, 2018

Source: https://www.globalkeysolutions.net/records/483/vilvet-pharmaceuticals-inc/419d1659-3828-40cf-9ae9-9afae4476089

> FDA 483 for Vilvet Pharmaceuticals Inc. on June 27, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vilvet Pharmaceuticals Inc.
- Inspection Date: 2018-06-27
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Vilvet Pharmaceutical, a manufacturer in Chester Springs, PA, was cited for significant deficiencies in its quality control unit during an FDA inspection. The firm lacks comprehensive written procedures and adequate oversight for critical functions, especially concerning its contract manufacturer of prescription drugs. This includes failures in reviewing batch records, assessing stability data, handling complaints, and approving various validation protocols, indicating a serious breakdown in quality assurance.

## Related Documents

- [483 - 2020-01-10](https://www.globalkeysolutions.net/records/483/vilvet-pharmaceuticals-inc/7c38082a-cb6e-4806-ab08-c9bc3eb2bdde)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)

Company: https://www.globalkeysolutions.net/companies/vilvet-pharmaceuticals-inc/6a3abef4-fdad-4616-9604-4356ac951d16

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8