FDA Inspection
Linde Gas North America LLCLinde Gas North America LLC – FDA Inspection, May 4, 2016
Record Details
This FDA Inspection record concerns Linde Gas North America LLC, with an inspection on May 4, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Linde Gas North America LLC
- Inspection Date
- May 4, 2016
- Product Type
- Drugs
View Company Profile
ID · 4c09bdab-7862-4fc8-9e7e-bf7866158ebc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 979083
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.89Quarantine of Rejected Components et. al.
- 21 CFR 211.160(b)(4)Written calibration procedures
- 21 CFR 211.198(a)Complaints reviewed by Quality Control Unit
- 21 CFR 211.100(b)SOPs not followed / documented
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