FDA Inspection
Wilson Medicine CompanyWilson Medicine Company – FDA Inspection, Mar 1, 2018
Record Details
This FDA Inspection record concerns Wilson Medicine Company, with an inspection on March 1, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 0befe801-de92-4272-89df-8ba98005fbd9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1043981
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.182Personnel dating/signing equipment log
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.42(c)(1)Incoming material area
- 21 CFR 211.67(b)Written procedures not established/followed
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