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FDA Inspection
•PT. Samudra Mandiri Sentosa•January 20, 2023

PT. Samudra Mandiri Sentosa – FDA Inspection, Jan 20, 2023

Record Details

This FDA Inspection record concerns PT. Samudra Mandiri Sentosa, with an inspection on January 20, 2023, issued by the Office of Inspections and Investigations.

Company
PT. Samudra Mandiri Sentosa
Inspection Date
January 20, 2023
Office
Office of Inspections and Investigations
Person
  • Clara E. Santiago (Issuing Officer)
View Company Profile

ID · e3e69279-d568-46c1-a4f9-855ff9c8e44b

Inspection Facts

Inspection number
1196636
FDA center
Foods & Cosmetics
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 108.35(c)(3)(i)Process adherence
  2. 21 CFR 113.100(b)Entry not timely
  3. 21 CFR 123.6(c)(2)Critical control points
  4. 21 CFR 123.6(c)(4)Monitoring - adequacy

Full citation text and observation details available on the Dashboard.

Other FDA inspections of PT. Samudra Mandiri Sentosa

1
DateClassificationOfficeProject area
January 15, 2019NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for PT. Samudra Mandiri Sentosa
  • FDA Inspection 1077304 - 2019-01-15

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