FDA Inspection
Hill LaboratoriesHill Laboratories – FDA Inspection, Sep 3, 2026
Record Details
This FDA Inspection record concerns Hill Laboratories, with an inspection on September 3, 2026, issued by the Philadelphia District Office, covering medical devices & rad health.
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ID · d86df5c7-3a0a-4828-b661-41abe27ba179
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1334112
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 6.2(e)Records of personnel competence not maintained
- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hill Laboratories
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2022 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 11, 2018 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| July 23, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Hill Laboratories
- FDA Inspection 1175601 - 2022-07-27
- FDA Inspection 1069431 - 2018-09-11
- FDA Inspection 935416 - 2015-07-23
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