FDA Inspection
Terve Sina Wellness Inc.Terve Sina Wellness Inc. – FDA Inspection, Dec 12, 2012
Record Details
This FDA Inspection record concerns Terve Sina Wellness Inc., with an inspection on December 12, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Terve Sina Wellness Inc.
- Inspection Date
- December 12, 2012
- Product Type
- Drugs
View Company Profile
ID · d42d3867-ab04-4239-bfbd-15519c72e551
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 812234
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.204Record information maintained
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
- 21 CFR 111.140(b)(1)Records - quality control operations; responsibilities
- 21 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Terve Sina Wellness Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| March 22, 2018 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| January 26, 2017 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 25, 2014 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Terve Sina Wellness Inc.
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.