Transdermal Delivery Solutions Corp. dba Hypospray Pharma – FDA 483, Dec 3, 2019
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.
- Inspection date
- December 3, 2019
- Product type
- drugs
ID · 8fcb85d5-8f0d-4369-bbf7-ddaaf926a927
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