FDA Inspection
Nelson Laboratories, LLCNelson Laboratories, LLC – FDA Inspection, Sep 26, 2025
Record Details
This FDA Inspection record concerns Nelson Laboratories, LLC, with an inspection on September 26, 2025, issued by the Chicago District Office, covering human drugs.
View Company Profile
ID · 7f04d17b-b5d6-4d7e-ab5e-0cf886ae47a8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1283842
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.160(b)(4)Test devices not meeting specifications
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(2)Stability sample storage conditions described
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Nelson Laboratories, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2024 | Not classified | Chicago District Office | |
| November 8, 2018 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| March 11, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 12, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 7, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Nelson Laboratories, LLC
- FDA Inspection 1242462 - 2024-07-25
- FDA Inspection 1073798 - 2018-11-08
- FDA Inspection 961743 - 2016-03-11
- FDA Inspection 835477 - 2013-06-12
- FDA Inspection 759436 - 2011-12-07
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.