FDA Inspection
Apex360, LLCApex360, LLC – FDA Inspection, Jul 7, 2016
Record Details
This FDA Inspection record concerns Apex360, LLC, with an inspection on July 7, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Apex360, LLC
- Inspection Date
- July 7, 2016
- Product Type
- Drugs
View Company Profile
ID · 1c42772e-682f-485c-ad37-81d3875103a3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 983399
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.122(a)Written procedures not followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Apex360, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 17, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 11, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Apex360, LLC
- FDA Inspection 1223277 - 2023-11-15
- FDA Inspection 1069143 - 2018-10-17
- FDA Inspection 714985 - 2011-03-11
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.