# FDA 483 - Synthetopes Inc - May 16, 2019

Source: https://www.globalkeysolutions.net/records/483/synthetopes-inc/90d41bdf-b76a-4990-9713-a22ebe38660d

> FDA 483 for Synthetopes Inc on May 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synthetopes Inc
- Inspection Date: 2019-05-16
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Synthetopes Inc, a producer of sterile drugs in Conway, SC, was cited for significant deficiencies in its manufacturing processes during an FDA inspection. The firm failed to conduct essential sterility and potency testing for its radiological and nuclear injectable drug products, lacked validation for aseptic processes and sterilization, and exhibited poor environmental monitoring and equipment sanitation. These issues indicate a severe lack of control over microbiological contamination and product quality, raising concerns about the safety and efficacy of its sterile drug products.

## Related Documents

- [483 - 2019-05-16](https://www.globalkeysolutions.net/records/483/synthetopes-inc/04d626b2-4a5a-401f-b61a-f8ef285ad44f)

## Related Officers

- [Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre](https://www.globalkeysolutions.net/people/jessica-l-pressley/2c190e50-81bd-4015-95f0-7177beb363bd)

Company: https://www.globalkeysolutions.net/companies/synthetopes-inc/be7d7bfa-a2b4-40cf-891c-161fb33d2984

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6