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FDA Inspection
•Alaska Spring Pharmaceuticals Inc.•July 29, 2024

Alaska Spring Pharmaceuticals Inc. – FDA Inspection, Jul 29, 2024

Record Details

This FDA Inspection record concerns Alaska Spring Pharmaceuticals Inc., with an inspection on July 29, 2024, issued by the New York District Office, covering foods & cosmetics.

Company
Alaska Spring Pharmaceuticals Inc.
Inspection Date
July 29, 2024
Product Type
Foods & Cosmetics
Office
New York District Office
People
  • Meredith P. Soehl (FDA Associated Person)
  • Shantel S. Tobias (Issuing Officer)
  • Siobhan G. Taylor (Issuing Officer)
View Company Profile

ID · 23c897d0-e174-4f48-9a77-ff8cbcf6f170

Inspection Facts

Inspection number
1242895
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ
Outcome
Form 483 issued

FDA Citations

18
  1. 21 CFR 111.113(a)(1)Quality control production, process control; material review, disposition
  2. 21 CFR 111.205(b)(2)Master manufacturing record - controls, procedures
  3. 21 CFR 111.210(b)Master manufacturing record - list components
  4. 21 CFR 111.210(g)Packaging description, representative label
  5. 21 CFR 111.210(h)(1)Instructions; specifications; packaged, labeled
  6. 21 CFR 111.255(b)Batch record - complete
  7. 21 CFR 111.27(d)Equipment - maintain, clean, sanitize
  8. 21 CFR 111.320(a)Examination, testing; appropriate
  9. 21 CFR 111.320(b)Examination, testing; scientifically valid
  10. 21 CFR 111.365(i)Metal, foreign material

Showing 10 of 18 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Alaska Spring Pharmaceuticals Inc.

4
DateClassificationOfficeProject area
November 9, 2021NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
December 21, 2017VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
December 10, 2014VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
January 6, 2014VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Alaska Spring Pharmaceuticals Inc.
  • FDA Inspection 1156287 - 2021-11-09
  • FDA Inspection 1035611 - 2017-12-21
  • FDA Inspection 906917 - 2014-12-10
  • FDA Inspection 862031 - 2014-01-06

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