# FDA 483 - Syntec Pharma Corp - October 28, 2020

Source: https://www.keypedia.com/records/483/syntec-pharma-corp/ffde4298-56e1-4b91-b51b-20f2e55aeff5

> FDA 483 for Syntec Pharma Corp on October 28, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Syntec Pharma Corp
- Inspection Date: 2020-10-28
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Syntec Pharma Corp. in Farmingdale, NY, revealed numerous significant deficiencies in their API repacking and relabeling operations. The firm failed to adequately separate hazardous materials, lacked validated cleaning procedures, and operated without an established quality unit. These critical issues indicate a severe lack of control over product quality, increasing the risk of cross-contamination and compromised drug integrity.

## Related Documents

- [WARNING_LETTER - 2020-10-28](https://www.keypedia.com/records/warning_letter/syntec-pharma-corp/ffa920fc-6555-4924-a681-d50843974068)

## Related Officers

- [Vivin George](https://www.keypedia.com/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)
- [investigator](https://www.keypedia.com/people/jay-wong/d58065c6-6c52-4d77-af6b-089176c778c9)

Company: https://www.keypedia.com/companies/syntec-pharma-corp/451da426-600b-4547-9521-d33743284d2b

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