FDA Inspection
St. Luke's Homestar Services, LlcSt. Luke's Homestar Services, Llc – FDA Inspection, Dec 22, 2009
Record Details
This FDA Inspection record concerns St. Luke's Homestar Services, Llc, with an inspection on December 22, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 22, 2009
- Product Type
- Drugs
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ID · f26256d0-2621-4b1c-b7ab-bca7098f7fae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 635720
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.188(b)(5)In-process and laboratory control results
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
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