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FDA Inspection
•Ecometics, Inc.•September 7, 2018

Ecometics, Inc. – FDA Inspection, Sep 7, 2018

Record Details

This FDA Inspection record concerns Ecometics, Inc., with an inspection on September 7, 2018, issued by the New England District Office, covering human drugs.

Company
Ecometics, Inc.
Inspection Date
September 7, 2018
Product Type
Human Drugs
Office
New England District Office
Person
  • Helen B. Ricalde (FDA Associated Person)
View Company Profile

ID · aba30053-4309-4d56-836c-da02100b31be

Inspection Facts

Inspection number
1065238
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

9
  1. 21 CFR 211.137(a)Expiration date lacking
  2. 21 CFR 211.142(b)Storage under appropriate conditions
  3. 21 CFR 211.165(b)Microbiological testing
  4. 21 CFR 211.165(e)Test methods
  5. 21 CFR 211.166(a)Written program not followed
  6. 21 CFR 211.58Buildings not maintained in good state of repair
  7. 21 CFR 211.65(a)Equipment construction - reactive surfaces
  8. 21 CFR 211.67(b)Written procedures not established/followed
  9. 21 CFR 211.80(b)Handling and Storage to Prevent Contamination

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Ecometics, Inc.

7
DateClassificationOfficeProject area
June 9, 2023VAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
February 6, 2023OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 10, 2021OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 29, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 26, 2013VAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
View all 7 other inspections on the company page
Other documents for Ecometics, Inc.
  • FDA Inspection 1207700 - 2023-06-09
  • FDA Inspection 1198801 - 2023-02-06
  • FDA Inspection 1151267 - 2021-09-10
  • FDA Inspection 987996 - 2016-09-29
  • FDA Inspection 827540 - 2013-04-26

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