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FDA Inspection
•Mechanical Servants LLC•May 10, 2018

Mechanical Servants LLC – FDA Inspection, May 10, 2018

Record Details

This FDA Inspection record concerns Mechanical Servants LLC, with an inspection on May 10, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Mechanical Servants LLC
Inspection Date
May 10, 2018
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Bryan L. Mcguckin
View Company Profile

ID · c6b57369-da5d-4f86-9f97-48cd98c06c06

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1051333
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

5
  1. 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
  2. 21 CFR 211.196Distribution Record Requirements
  3. 21 CFR 211.122(b)Labeling and packaging improperly approved/released
  4. 21 CFR 211.22(a)Approve or reject components, products
  5. 21 CFR 211.192Investigations of discrepancies, failures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Mechanical Servants LLC

4
DateClassificationOfficeProject area
September 29, 2021NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
September 19, 2018NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
September 24, 2015NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
November 13, 2012VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Mechanical Servants LLC
  • FDA Inspection 1153935 - 2021-09-29
  • FDA Inspection 1067135 - 2018-09-19
  • FDA Inspection 943092 - 2015-09-24
  • FDA Inspection 805628 - 2012-11-13

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