FDA Inspection
True Function Laboratory, Inc.True Function Laboratory, Inc. – FDA Inspection, Aug 7, 2023
Record Details
This FDA Inspection record concerns True Function Laboratory, Inc., with an inspection on August 7, 2023, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · e1e6e911-8c93-44ec-9581-a50e8b469316
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1211620
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(b)Review and evaluation for investigation
Showing 10 of 14 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of True Function Laboratory, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2025 | Not classified | Los Angeles District Office | Compliance: Medical Devices |
| March 19, 2019 | Not classified | Los Angeles District Office |
Other documents for True Function Laboratory, 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.