FDA Inspection
PhamatechPhamatech – FDA Inspection, Jan 23, 2020
Record Details
This FDA Inspection record concerns Phamatech, with an inspection on January 23, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Phamatech
- Inspection Date
- January 23, 2020
- Product Type
- Devices
View Company Profile
ID · 7a4e16fb-a7c1-44de-9080-a0f3db7adb28
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1117542
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Production processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Phamatech
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2025 | Not classified | Los Angeles District Office | |
| December 15, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 28, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Phamatech
- FDA Inspection 1262990 - 2025-02-11
- FDA Inspection 1194665 - 2022-12-15
- FDA Inspection 893177 - 2014-08-28
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