1152591

Yusef Manufacturing Laboratories, LLC — FEI 3004845420

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 24, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Clearfield, UT (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
117721 CFR 211.63Equipment Design, Size and Location
126321 CFR 211.68(b)Computer control of master formula records
127021 CFR 211.68(b)input/output verification
136121 CFR 211.100(a)Absence of Written Procedures
176721 CFR 211.137(a)Expiration date lacking
181021 CFR 211.160(a)Lab controls established, including changes
188321 CFR 211.165(a)Testing and release for distribution
188521 CFR 211.165(b)Microbiological testing
189021 CFR 211.165(e)Test methods
191221 CFR 211.166(a)Written program not followed
194321 CFR 211.180(e)(1)Review of representative number of batches
200721 CFR 211.186(a)Signature and checking of records -- 2 persons
201821 CFR 211.188(b)(6)Documentation of Packaging and Labeling Area Inspections
202721 CFR 211.192Investigations of discrepancies, failures
203321 CFR 211.194(c)Testing and standardization of standards et. al.
239721 CFR 211.194(a)(1)Description and Identification of Samples
239921 CFR 211.194(a)(2)Laboratory Test Method Verification
241921 CFR 211.198(a)Complaint Handling Procedure
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
354721 CFR 211.46(b)Equipment for Environmental Control
360321 CFR 211.160(b)Scientifically sound laboratory controls
361421 CFR 211.160(b)(4)Written calibration procedures
363221 CFR 211.170(b)Annual visual exams of drug products
430321 CFR 211.67(b)Written procedures fail to include
430521 CFR 211.68(b)Backup data not assured as exact and complete
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
440221 CFR 211.192Written record of investigation incomplete
440421 CFR 211.194(a)(1)Sample identification and other information