FDA Inspection
Wallsburg Farms Inc.Wallsburg Farms Inc. – FDA Inspection, Feb 16, 2018
Record Details
This FDA Inspection record concerns Wallsburg Farms Inc., with an inspection on February 16, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4a475b56-4524-4775-a070-8fada61039cb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041721
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.130(e)Packaging line inspection documentation
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.100(a)Absence of Written Procedures
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