FDA Inspection
Holston Gases, Inc.Holston Gases, Inc. – FDA Inspection, Dec 2, 2011
Record Details
This FDA Inspection record concerns Holston Gases, Inc., with an inspection on December 2, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Holston Gases, Inc.
- Inspection Date
- December 2, 2011
- Product Type
- Drugs
View Company Profile
ID · e74a5b1c-4d3d-406c-b5b2-0e1e14059c21
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 754165
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188(b)(5)In-process and laboratory control results
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.89Quarantine of Rejected Components et. al.
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.122(a)Written procedures not followed
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