FDA Inspection
East Coast Oxygen & Hydro Testing Inc.East Coast Oxygen & Hydro Testing Inc. – FDA Inspection, Sep 16, 2016
Record Details
This FDA Inspection record concerns East Coast Oxygen & Hydro Testing Inc., with an inspection on September 16, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 16, 2016
- Product Type
- Drugs
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ID · d79fda17-9752-4faf-9883-e8e92261ceac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986365
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.101(b)Measured components for manufacturing
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.188(a)Accurate reproduction
- 21 CFR 211.188(b)(7)Documentation of Actual Yield and Theoretical Yield
- 21 CFR 211.188(b)(3)Identification of Components and In-Process Materials
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.67(b)Written procedures not established/followed
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