Able Groupe Inc

FDA Regulatory Profile

Able Groupe Inc appears in FDA public data with 21 recalls — including 8 Class I (most serious) —, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (F-0927-2021, Class II) was initiated on August 8, 2021.

Summary

Total Recalls
21 (8 Class I)
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
F-0927-2021Class IIKendamil Organic Stage 2 Follow on Milk FormulaAugust 8, 2021
F-0924-2021Class IHiPP UK Stage 1 Combiotic First Infant Milk FormulaAugust 8, 2021
F-0907-2021Class IHiPP Comfort Milk FormulaAugust 8, 2021
F-0919-2021Class IIHolle Goat Stage 1 Organic Infant Milk FormulaAugust 8, 2021
F-0912-2021Class IIHiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk FormulaAugust 8, 2021
F-0920-2021Class IIHolle Goat Stage 2 Organic Follow-On Infant Milk FormulaAugust 8, 2021
F-0913-2021Class IIHiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk FormulaAugust 8, 2021
F-0925-2021Class IIHiPP UK Stage 2 Combiotic Follow-On Infant Milk FormulaAugust 8, 2021
F-0910-2021Class IHiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk FormulaAugust 8, 2021
F-0923-2021Class IILebenswert Folgemilch Stage 3 Organic Toddler FormulaAugust 8, 2021
F-0922-2021Class IILebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk FormulaAugust 8, 2021
F-0917-2021Class IHolle Bio Stage PRE Organic Infant Milk FormulaAugust 8, 2021
F-0926-2021Class IIKendamil Organic Stage 1 First Infant Milk FormulaAugust 8, 2021
F-0921-2021Class ILebenswert Anfangsmilch Stage 1 Organic Infant Milk FormulaAugust 8, 2021
F-0911-2021Class IIHiPP Dutch Stage 2 Combiotic Follow-on Milk FormulaAugust 8, 2021
F-0916-2021Class IHolle Bio Stage 1 Organic Infant Milk FormulaAugust 8, 2021
F-0914-2021Class IHiPP German Stage 1 Combiotic Infant Milk FormulaAugust 8, 2021
F-0908-2021Class IIHiPP AR Germany Anti-Reflux Milk FormulaAugust 8, 2021
F-0909-2021Class IHiPP Dutch Stage 1 Combiotic Infant Milk FormulaAugust 8, 2021
F-0915-2021Class IIHiPP German Stage 2 Combiotic Follow-on Infant Milk FormulaAugust 8, 2021