FDA Inspection
Waterlab CorporationWaterlab Corporation – FDA Inspection, Jul 30, 2021
Record Details
This FDA Inspection record concerns Waterlab Corporation, with an inspection on July 30, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Waterlab Corporation
- Inspection Date
- July 30, 2021
- Product Type
- Drugs
View Company Profile
ID · 2717ea1b-50bf-4f01-a711-3e43e4119886
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1147970
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.194(a)(2)Laboratory Test Method Verification
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