FDA Inspection
Hudson Respiratory Care Tecate S. de RL de CVHudson Respiratory Care Tecate S. de RL de CV – FDA Inspection, Jan 12, 2012
Record Details
This FDA Inspection record concerns Hudson Respiratory Care Tecate S. de RL de CV, with an inspection on January 12, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 12, 2012
- Product Type
- Devices
View Company Profile
ID · 7cf216cb-43a0-40b4-ba91-45e35dcda190
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 769052
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hudson Respiratory Care Tecate S. de RL de CV
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 29, 2023 | Not classified | Office of Inspections and Investigations | |
| December 9, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 2, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Hudson Respiratory Care Tecate S. de RL de CV
- FDA Inspection 1210503 - 2023-06-29
- FDA Inspection 1195100 - 2022-12-09
- FDA Inspection 1065507 - 2018-08-02
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.