FDA Inspection
Molecular Biologicals, LLCMolecular Biologicals, LLC – FDA Inspection, Sep 26, 2019
Record Details
This FDA Inspection record concerns Molecular Biologicals, LLC, with an inspection on September 26, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d9511ad0-7764-46af-a41e-76eba84d5144
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102841
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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