FDA Inspection
Kryolan GmbHKryolan GmbH – FDA Inspection, Nov 14, 2014
Record Details
This FDA Inspection record concerns Kryolan GmbH, with an inspection on November 14, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Kryolan GmbH
- Inspection Date
- November 14, 2014
- Product Type
- Drugs
View Company Profile
ID · 7e3a210e-05bf-4a60-8bc9-a4e5e3ae40c3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 906221
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.80(a)Procedures To Be in Writing
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