FDA Inspection
Vertical Pharmaceuticals, LLCVertical Pharmaceuticals, LLC – FDA Inspection, Nov 1, 2016
Record Details
This FDA Inspection record concerns Vertical Pharmaceuticals, LLC, with an inspection on November 1, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · f4fa4d2b-01ac-4a30-a3f3-16de849d7718
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 993082
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 314.80(b)Failure to review ADE information
- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Interval
- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vertical Pharmaceuticals, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2023 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 25, 2019 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 18, 2018 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 20, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2010 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Vertical Pharmaceuticals, LLC
- FDA Inspection 1222553 - 2023-09-26
- FDA Inspection 1106926 - 2019-09-25
- FDA Inspection 1059217 - 2018-07-18
- FDA Inspection 704957 - 2010-12-20
- FDA Inspection 646066 - 2010-02-24
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.