FDA Inspection
Marley Biotechnology IncMarley Biotechnology Inc – FDA Inspection, Sep 18, 2026
Record Details
This FDA Inspection record concerns Marley Biotechnology Inc, with an inspection on September 18, 2026, issued by the New York District Office, covering animal drugs & feeds.
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ID · 29d42540-8dab-402a-b701-bd00b48a820a
Inspection Facts
- Inspection number
- 1337256
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
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