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FDA Inspection
•Botanic Beauty Products, Inc.•February 2, 2018

Botanic Beauty Products, Inc. – FDA Inspection, Feb 2, 2018

Record Details

This FDA Inspection record concerns Botanic Beauty Products, Inc., with an inspection on February 2, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Botanic Beauty Products, Inc.
Inspection Date
February 2, 2018
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Zachary A. Bogorad
View Company Profile

ID · 9ad27187-bbac-42bd-8b2c-dc97f55a82f9

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1039510
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

7
  1. 21 CFR 211.188Prepared for each batch, include complete information
  2. 21 CFR 211.110(a)Control procedures to monitor and validate performance
  3. 21 CFR 211.137(a)Expiration date lacking
  4. 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
  5. 21 CFR 211.25(b)Supervisor Training/Education/Experience
  6. 21 CFR 211.160(b)Scientifically sound laboratory controls
  7. 21 CFR 211.22(c)Approve or reject procedures or specs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Botanic Beauty Products, Inc.

2
DateClassificationOfficeProject area
December 5, 2022NAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
June 7, 2018VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Botanic Beauty Products, Inc.
  • FDA Inspection 1193402 - 2022-12-05
  • FDA Inspection 1055104 - 2018-06-07

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