FDA Inspection 1002301 — Royal Chemical Company

Royal Chemical Company — FEI 2517008

The FDA completed an inspection of Royal Chemical Company on Feb 28, 2017 in E Stroudsburg, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Feb 28, 2017
Fiscal Year
2017
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
E Stroudsburg, PA (United States)

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
203121 CFR 211.194(a)Complete test data included in records
240521 CFR 211.194(a)(7)Identification of Person Performing the Testing
358121 CFR 211.101(d)Verification of component addition

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.