FDA Inspection
Wellness Pharmacy, Inc.Wellness Pharmacy, Inc. – FDA Inspection, Sep 30, 2014
Record Details
This FDA Inspection record concerns Wellness Pharmacy, Inc., with an inspection on September 30, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Wellness Pharmacy, Inc.
- Inspection Date
- September 30, 2014
- Product Type
- Drugs
View Company Profile
ID · 1aa74492-20b2-4c94-923f-b99643b009e9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 900389
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- State Referral Letter
FDA Citations
9- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
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