FDA Inspection
Pacific Instruments, Inc.Pacific Instruments, Inc. – FDA Inspection, Dec 15, 2016
Record Details
This FDA Inspection record concerns Pacific Instruments, Inc., with an inspection on December 15, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Seema S. Singh (Issuing Officer)
View Company Profile
ID · 4246f0fd-5b97-4170-83bf-fdf5dc997401
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 998180
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.50(a)(1)Documented evaluation
Full citation text and observation details available on the Dashboard.
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.