Wellspring Pharmaceutical Corporation

FDA Regulatory Profile

Wellspring Pharmaceutical Corporation appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2112-2014, Class I) was initiated on March 25, 2014. Its most recent 510(k) clearance was granted on September 1, 2021.

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2112-2014Class IIPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.March 25, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K211823Bonine Acupressure BandsSeptember 1, 2021