FDA Inspection
Monogram Biosciences-LabcorpMonogram Biosciences-Labcorp – FDA Inspection, Sep 25, 2026
Record Details
This FDA Inspection record concerns Monogram Biosciences-Labcorp, with an inspection on September 25, 2026, issued by the San Francisco District Office, covering medical devices & rad health.
- Company
- Monogram Biosciences-Labcorp
- Inspection Date
- September 25, 2026
- Product Type
- Medical Devices & Rad Health
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ID · fc6900c0-860b-482d-a11e-1990730bdf4b
Inspection Facts
- Inspection number
- 1337970
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 8.3.1Records of nonconforming product and actions taken not maintained
- ISO 13485:2016 Clause 8.5.2Corrective actions were unduly delayed
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Other FDA inspections of Monogram Biosciences-Labcorp
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2023 | Not classified | San Francisco District Office |
Other documents for Monogram Biosciences-Labcorp
- FDA Inspection 1223683 - 2023-10-27
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