# FDA 483 - Vitane Pharmaceutical, Inc. - October 23, 2024

Source: https://www.globalkeysolutions.net/records/483/vitane-pharmaceutical-inc/89ca698e-be71-48ec-a1eb-8807de58884a

> FDA 483 for Vitane Pharmaceutical, Inc. on October 23, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vitane Pharmaceutical, Inc.
- Inspection Date: 2024-10-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Vitane Pharmaceutical, Inc. in Congers, NY, was inspected regarding its drug product repackaging and relabeling operations. The inspection revealed significant deficiencies across multiple areas, including a lack of validated production and process controls, inadequate equipment cleaning validation, insufficient supplier qualification, improper drug product storage conditions, and a failure to conduct annual product reviews. These issues indicate a systemic lack of adherence to quality standards for drug products.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/divek-r-jumani/ba9b28e9-d9b3-4c9f-8532-25f037ff7ce4)
- [issuing_officer](https://www.globalkeysolutions.net/people/gam-s-zamil/75bc04d4-6013-43b5-8200-8b513c814a7c)

Company: https://www.globalkeysolutions.net/companies/vitane-pharmaceutical-inc/f13c777d-128f-40c7-a634-99c446b6799c

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