FDA Inspection 708823 — Twenty-First Century Healthcare Inc

Twenty-First Century Healthcare Inc — FEI 1000160551

The FDA completed an inspection of Twenty-First Century Healthcare Inc on January 28, 2011 in Tempe, AZ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 28, 2011
Fiscal Year
2011
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Tempe, AZ (United States)

Citations

IDCFRDescription
1550121 CFR 111.27(a)(3)(i)Equipment - installed to facilitate cleaning
1568121 CFR 111.315(d)Standard reference materials; criteria for selecting
1568321 CFR 111.315(c)Examination, testing methods; criteria for selecting
1586121 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
1587221 CFR 111.75(c)(3)Specifications met identity,purity, strength, comp,; basis
1592721 CFR 111.103Written procedures - quality control operations
1608521 CFR 111.75(c)(3)Specifications met limits on contamination ; basis