FDA Inspection
Roberts Home Medical LLCRoberts Home Medical LLC – FDA Inspection, Dec 21, 2018
Record Details
This FDA Inspection record concerns Roberts Home Medical LLC, with an inspection on December 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 47cc7967-1eef-441f-8a24-f602b8c50546
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1075937
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.160(b)(4)Written calibration procedures
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.198(a)Reporting of adverse drug experience to FDA
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