FDA Inspection
ChemSolv IncorporatedChemSolv Incorporated – FDA Inspection, Mar 11, 2011
Record Details
This FDA Inspection record concerns ChemSolv Incorporated, with an inspection on March 11, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ChemSolv Incorporated
- Inspection Date
- March 11, 2011
- Product Type
- Drugs
View Company Profile
ID · afb3af83-e737-415f-84f4-ee98924e8bb6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 713550
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(c)(1)Containers cleaned before sampling
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.100(b)SOPs not followed / documented
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