FDA Inspection
PT. Samudra Mandiri SentosaPT. 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
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- 21 CFR 108.35(c)(3)(i)Process adherence
- 21 CFR 113.100(b)Entry not timely
- 21 CFR 123.6(c)(2)Critical control points
- 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| Date | Classification | Office | Project area |
|---|---|---|---|
| January 15, 2019 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for PT. Samudra Mandiri Sentosa
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.