FDA Inspection
Daniels Manufacturing Operations IncDaniels Manufacturing Operations Inc – FDA Inspection, Nov 8, 2023
Record Details
This FDA Inspection record concerns Daniels Manufacturing Operations Inc, with an inspection on November 8, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 34cbe85b-164e-4734-92c7-d1677fad51ba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1222883
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
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