FDA Inspection
First Community Care LLCFirst Community Care LLC – FDA Inspection, Apr 16, 2015
Record Details
This FDA Inspection record concerns First Community Care LLC, with an inspection on April 16, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- First Community Care LLC
- Inspection Date
- April 16, 2015
- Product Type
- Drugs
View Company Profile
ID · 12a6eb7d-10c3-4cad-97a5-b3bde4f1e85a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 922515
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(a)Written Procedures Not Followed
- 21 CFR 211.165(c)Sampling and testing plans not followed
- 21 CFR 211.100(b)SOPs not followed / documented
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