FDA Inspection
Air Liquide Canada Inc.Air Liquide Canada Inc. – FDA Inspection, Mar 13, 2020
Record Details
This FDA Inspection record concerns Air Liquide Canada Inc., with an inspection on March 13, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Air Liquide Canada Inc.
- Inspection Date
- March 13, 2020
- Product Type
- Drugs
View Company Profile
ID · 7f4599c6-a385-4765-8da2-c88ad7f0f8e2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1120599
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(a)GMP Training Frequency
- 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 211.25(c)Inadequate number of personnel
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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