# FDA 483 - Kreitchman PET Center - September 13, 2019

Source: https://www.globalkeysolutions.net/records/483/kreitchman-pet-center/6ef6188b-8a64-4a83-8566-4c932536b85c

> FDA 483 for Kreitchman PET Center on September 13, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Kreitchman PET Center
- Inspection Date: 2019-09-13
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Kreitchman PET Center in New York, NY, a PET drug manufacturer, revealed significant deficiencies across multiple areas. The firm failed to adequately investigate out-of-specification results and discrepancies, lacked proper written production and process control procedures, and maintained unsuitable laboratory analytical methods. Additionally, there were no established quality assurance procedures for data review and inadequate control over laboratory reagents and supplies, including expired materials.

## Related Documents

- [483 - 2025-09-02](https://www.globalkeysolutions.net/records/483/kreitchman-pet-center/29d4d12f-8864-42fb-b3c8-ac04685804d6)

## Related Officers

- [Dhanalakshmi Kaci](https://www.globalkeysolutions.net/people/dhanalakshmi-kaci/b408b4bc-e6f2-48b6-81d7-72ecbcd6b917)
- [Director, Enterprise Regulatory Compliance](https://www.globalkeysolutions.net/people/nicholas-a-violand/c0c3ee7a-8adb-43d2-974c-06220ef8e8eb)

Company: https://www.globalkeysolutions.net/companies/kreitchman-pet-center/87f43140-42b5-46af-ba39-2f0621ab9f24

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