# FDA 483 - Transdermal Delivery Solutions Corp. dba Hypospray Pharma - December 03, 2019

Source: https://www.globalkeysolutions.net/records/483/transdermal-delivery-solutions-corp-dba-hypospray-pharma/8fcb85d5-8f0d-4369-bbf7-ddaaf926a927

> FDA 483 for Transdermal Delivery Solutions Corp. dba Hypospray Pharma on December 03, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Transdermal Delivery Solutions Corp. dba Hypospray Pharma
- Inspection Date: 2019-12-03
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Transdermal Delivery Solutions Corp. dba Hypospray Pharma in Palm Beach Gardens, FL, a drug manufacturer, was cited for multiple significant cGMP deficiencies during an FDA inspection. The observations highlight a pervasive lack of quality oversight, including failures in quality unit responsibilities, investigation of out-of-specification results, equipment control, stability data for expiration dating, and labeling controls. These issues indicate a broad breakdown in the firm's quality system.

## Related Officers

- [Jennifer L. Huntington](https://www.globalkeysolutions.net/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.globalkeysolutions.net/companies/transdermal-delivery-solutions-corp-dba-hypospray-pharma/f1f6c266-f4d2-4f72-b1cb-1a2c8b3b4ddf

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