FDA Inspection
Tri-County Homecare Services LLCTri-County Homecare Services LLC – FDA Inspection, Sep 29, 2011
Record Details
This FDA Inspection record concerns Tri-County Homecare Services LLC, with an inspection on September 29, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 29, 2011
- Product Type
- Drugs
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ID · 8bfc86d7-b719-474e-897d-00be3308d539
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 747424
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.188(b)(3)Identification of each component or in-process material
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(a)Accurate reproduction
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Tri-County Homecare Services LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Tri-County Homecare Services LLC
- FDA Inspection 794878 - 2012-08-09
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