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FDA Inspection
•LKR Imports•May 16, 2014

LKR Imports – FDA Inspection, May 16, 2014

Record Details

This FDA Inspection record concerns LKR Imports, with an inspection on May 16, 2014, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
LKR Imports
Inspection Date
May 16, 2014
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · 62f99dde-424c-4f10-982c-856736ca8899

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
872457
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

10
  1. 21 CFR 111.103Written procedures - quality control operations
  2. 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
  3. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  4. 21 CFR 111.95(b)(2)Documentation - supplier qualification
  5. 21 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
  6. 21 CFR 111.475(b)(1)Written procedures - holding; distributing
  7. 21 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
  8. 21 CFR 111.255(a)Batch record - every batch
  9. 21 CFR 111.205(a)Master manufacturing record - each batch
  10. 21 CFR 111.75(c)Specifications met - verify; finished batch

Full citation text and observation details available on the Dashboard.

Other FDA inspections of LKR Imports

2
DateClassificationOfficeProject area
January 25, 2017VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
June 7, 2010VAICenter for Drug Evaluation and ResearchUnapproved and Misbranded Drugs
Other documents for LKR Imports
  • FDA Inspection 1044430 - 2017-01-25
  • FDA Inspection 673151 - 2010-06-07

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