# FDA 483 - PETNET Solutions, Inc. - February 19, 2016

Source: https://www.globalkeysolutions.net/records/483/petnet-solutions-inc/bcca9621-6046-4f53-b2fb-dc07f0a98259

> FDA 483 for PETNET Solutions, Inc. on February 19, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PETNET Solutions, Inc.
- Inspection Date: 2016-02-19
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Pet Net Solutions, Inc., a Positron Emission Tomography (PET) drug manufacturer in Fort Lauderdale, FL, revealed significant deficiencies in facility controls and aseptic processing. Observations included inadequate environmental monitoring during mold remediation, insufficient cleaning and sanitation procedures, and a lack of dynamic smoke studies. Furthermore, the firm's media fills failed to incorporate routine process interruptions, compromising the validation of aseptic technique.

## Related Officers

- [Ileana Barreto-Petit](https://www.globalkeysolutions.net/people/ileana-barreto-petit/e5c865ac-14a2-47d4-954b-464a865e8684)
- [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/petnet-solutions-inc/11f6bbf6-b189-4b6d-87bf-8ff12e8d1d23

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