FDA Inspection
Vertical Pharmaceuticals, LLCVertical Pharmaceuticals, LLC – FDA Inspection, Feb 24, 2010
Record Details
This FDA Inspection record concerns Vertical Pharmaceuticals, LLC, with an inspection on February 24, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 24, 2010
- Product Type
- Drugs
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ID · 9c142a59-a92b-487c-91d8-54734bb25db2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 646066
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.180(e)(1)Review of representative number of batches
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 |
| November 1, 2016 | OAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 20, 2010 | VAI | 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 993082 - 2016-11-01
- FDA Inspection 704957 - 2010-12-20
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