1074873

X TECH CO-PACKERS, LLC — FEI 3009469622

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 18, 2018
Fiscal Year
2019
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Orem, UT (United States)

Citations

IDCFRDescription
109821 CFR 211.22(c)Approve or reject procedures or specs
111121 CFR 211.25(a)Training , Education , Experience overall
115921 CFR 211.28(a)Clothing appropriate for duties performed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145221 CFR 211.113(b)Validation lacking for sterile drug products
1553221 CFR 111.255(b)Batch record - complete
1576321 CFR 111.205(a)Master manufacturing record - unique formulation
1577521 CFR 111.415(e)Dietary supplement containers - mix-ups
1580021 CFR 111.560(a)(2)Product complaint - quality control investigate
1582921 CFR 111.70(b)(1)Specifications - component identity
1583021 CFR 111.70(b)(2)Specifications-component purity, strength, composition
1583921 CFR 111.70(e)Specifications - identity, purity, strength, composition
1587221 CFR 111.75(c)(3)Specifications met identity,purity, strength, comp,; basis
1593821 CFR 111.105(f)Quality control - representative samples
1595421 CFR 111.113(a)(2)Quality control master manufacturing record; material review, disposition
1597721 CFR 111.123(a)(1)Quality control operations - master manufacturing record, modifications
1597821 CFR 111.123(a)(2)Quality control operations - batch production records
1605821 CFR 111.535(b)(2)Records - ret'nd dietary supplement: material review, dispos
186921 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
188321 CFR 211.165(a)Testing and release for distribution
202721 CFR 211.192Investigations of discrepancies, failures
356221 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
358521 CFR 211.110(a)Control procedures to monitor and validate performance
361021 CFR 211.160(b)(3)Drug product sample
363221 CFR 211.170(b)Annual visual exams of drug products
432021 CFR 211.84(d)(6)Microbiological Contamination Exam
438221 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
439121 CFR 211.180(e)(2)Items to cover on annual reviews