TerSera Therapeutics LLC

FDA Regulatory Profile

TerSera Therapeutics LLC has 1 FDA recall, 1 inspection, 0 510(k) clearances and 0 compliance actions on record.

Latest recall
D-0875-2026 · Class II · Aug 31, 2026
Latest inspection
Oct 5, 2023 · NAI

Updated: recalls Oct 23, 2026 · inspections Oct 23, 2026 · compliance actions Oct 23, 2026.

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Summary

Recalls
1
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0875-2026Class IIZoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only…Aug 31, 2026

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 5, 2023Deerfield, ILDrugsNo Action Indicated (NAI)3016527790

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.