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FDA Inspection
•Ceba-Tek, Inc.•February 17, 2023

Ceba-Tek, Inc. – FDA Inspection, Feb 17, 2023

Record Details

This FDA Inspection record concerns Ceba-Tek, Inc., with an inspection on February 17, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Ceba-Tek, Inc.
Inspection Date
February 17, 2023
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
People
  • Jason P. Aun (Company Rep)
  • Juan C. Gonzalez Rivera (Issuing Officer)
View Company Profile

ID · a817aae3-5e68-45a2-ba2a-66a2db521c51

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
1197690
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ
Outcome
Form 483 issued

FDA Citations

14
  1. 21 CFR 111.70(b)(1)Specifications - component identity
  2. 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
  3. 21 CFR 111.70(e)Specifications - contamination limits
  4. 21 CFR 111.27(d)Equipment - maintain, clean, sanitize
  5. 21 CFR 111.205(a)Master manufacturing record - each batch
  6. 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
  7. 21 CFR 111.30(e)Equipment - controls - QC
  8. 21 CFR 111.205(a)Master manufacturing record - each batch
  9. 21 CFR 111.27(d)Equipment - maintain, clean, sanitize
  10. 21 CFR 111.30(e)Equipment - controls - QC

Showing 10 of 14 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Ceba-Tek, Inc.

5
DateClassificationOfficeProject area
August 31, 2023Not classifiedFlorida District Office
August 17, 2021OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
February 5, 2019OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
November 12, 2015VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
April 25, 2014VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Ceba-Tek, Inc.
  • FDA Inspection 1216783 - 2023-08-31
  • FDA Inspection 1149198 - 2021-08-17
  • FDA Inspection 1078174 - 2019-02-05
  • FDA Inspection 948195 - 2015-11-12
  • FDA Inspection 877539 - 2014-04-25

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