1087365

Swabplus, L.P. — FEI 3003053677

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
April 11, 2019
Fiscal Year
2019
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Rancho Cucamonga, CA (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
125621 CFR 211.68(b)Backup file not maintained
126321 CFR 211.68(b)Computer control of master formula records
145021 CFR 211.113(a)Procedures for non-sterile drug products
154021 CFR 211.125(a)Strict control not exercised over labeling issued
188321 CFR 211.165(a)Testing and release for distribution
189021 CFR 211.165(e)Test methods
194321 CFR 211.180(e)(1)Review of representative number of batches
360321 CFR 211.160(b)Scientifically sound laboratory controls
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
457621 CFR 211.192No written record of investigation