725281

Sunfood Corporation — FEI 3006552406

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 24, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
El Cajon, CA (United States)

Citations

IDCFRDescription
122721 CFR 211.67(c)Cleaning/maintenance records not kept
136121 CFR 211.100(a)Absence of Written Procedures
139521 CFR 211.103Actual vs. theoretical yields not determined
1544621 CFR 111.15(c)(2)Toxic materials - use
1544721 CFR 111.15(c)(3)Cleaning compounds and toxic materials - holding
1545021 CFR 111.15(f)(3)Plumbing - source of contamination
1545321 CFR 111.16Written procedures - cleaning
1549421 CFR 111.25(c)Procedures - equipment - cleaning, sanitizing
1549821 CFR 111.27(d)Equipment - maintain, clean, sanitize
155021 CFR 211.125(f)Procedures Written and Followed
1553221 CFR 111.255(b)Batch record - complete
1559721 CFR 111.160(c)(3)Labels - quality control; approve, release
1567521 CFR 111.315(b)Sampling plans; establish, follow
1569121 CFR 111.315(b)(2)Sampling plans; in-process materials
1573621 CFR 111.353Manufacturing operations - written procedures
1578321 CFR 111.410(d)Manufacturing history
1578621 CFR 111.410(b)Labels - issuance, use
1578721 CFR 111.410(b)Packaging - issuance, use
1582821 CFR 111.70(a)Specifications - manufacturing process
1583821 CFR 111.70(d)Specifications - labels, packaging
1586121 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
1589021 CFR 111.80(a)Components packaging, labels used
1593221 CFR 111.105(a)Quality control - processes, specifications, written procedures
1596721 CFR 111.117(b)Quality control operations - calibration records
163021 CFR 211.130(b)Unlabeled filled containers controls
178721 CFR 211.80(a)Procedures To Be in Writing
180221 CFR 211.84(b)Representative Samples
200821 CFR 211.186(a)Written procedures followed
200921 CFR 211.188Prepared for each batch, include complete information
432421 CFR 211.110(b)In-process materials specifications testing