Graceleigh, Inc.
FEI 3011837162 · 3471 Via Lido Ste 207, Newport Beach, California, 92663-3929, United States
1 warning letter on record
Per FDA, as of 2026-10-31 · Sources: FDA Data Dashboard, Import Alerts, Enforcement Reports
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Import alerts
0
Import refusals (5 years)
0
Warning letters
1
Last FDA action
2024-08-14
2 years ago
FDA record
- 2024-04-18RecallRecall F-1247-2024 · Class 1 · FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading information that implied the product was safe for use as a sole source of nutrition for infants. Sammy's Milk has not submitted to FDA the premarket notification required for an infant formula, and the product is not manufactured in compliance with the infant formula requirements.Sammy's Milk GOAT MILK TODDLER FORMULA, 25.68 oz (78g) pouchSource: FDA Enforcement Reports
- 2024-04-18RecallRecall F-1248-2024 · Class 1 · FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading information that implied the product was safe as a sole source of nutrition for infants. Sammy's Milk has not submitted to FDA the premarket notification required for an infant formula, and the product is not manufactured in compliance with the infant formula requirements.Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick PakSource: FDA Enforcement Reports
- 2016-09-30RecallRecall F-1724-2017 · Class 1 · Graceleigh, Inc. dba Sammys Milk is recalling certain lots of Sammys Milk (Baby Food) because of possible presence of Cronobacter, a bacteria that can cause severe and sometimes fatal bloom infections or meningitis in infants (under 12 months of age) and it may not provide adequate nutritional levels of iron.Sammy's Milk (Baby Food), Net Wt. 12.84 oz (364 g), 6 containers per caseSource: FDA Enforcement Reports