FDA Inspection
Tri-Med, Inc. dba Advanced Care Infusion-ShelbyFDA Inspection 915892 - Tri-Med, Inc. dba Advanced Care Infusion-Shelby - February 23, 2015
Record Details
This FDA Inspection record concerns Tri-Med, Inc. dba Advanced Care Infusion-Shelby, with an inspection on February 23, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 23, 2015
- Product Type
- Drugs
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ID · b90ac475-6840-45c6-b9e8-269b7e2324d1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 915892
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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