FDA Inspection
P & R Home IV Service IncP & R Home IV Service Inc – FDA Inspection, Aug 11, 2011
Record Details
This FDA Inspection record concerns P & R Home IV Service Inc, with an inspection on August 11, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- P & R Home IV Service Inc
- Inspection Date
- August 11, 2011
- Product Type
- Drugs
View Company Profile
ID · 68275606-6e32-4e64-932b-666f03c84df4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 739030
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.188(b)(3)Identification of each component or in-process material
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.122(c)Records fail to include
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.80(a)Written Procedures Not Followed
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