FDA Inspection
BPI LabsBPI Labs – FDA Inspection, Jun 12, 2019
Record Details
This FDA Inspection record concerns BPI Labs, with an inspection on June 12, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a6717794-597c-4253-848d-200c476bd040
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1092697
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
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Other FDA inspections of BPI Labs
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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