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FDA Inspection
•Velocity Pharma LLC•December 14, 2023

Velocity Pharma LLC – FDA Inspection, Dec 14, 2023

Record Details

This FDA Inspection record concerns Velocity Pharma LLC, with an inspection on December 14, 2023, covering drugs.

Company
Velocity Pharma LLC
Inspection Date
December 14, 2023
Product Type
Drugs
People
  • Anastasia M. Shields (FDA Associated Person)
  • Syeda N. Mahazabin (FDA Associated Person)
View Company Profile

ID · 266e0974-396f-47b6-89f1-20b94c0dc58f

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
1225060
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 211.142(b)Storage under appropriate conditions
  2. 21 CFR 211.150(b)Recall facilitation
  3. 21 CFR 211.196Distribution Record Requirements
  4. 21 CFR 211.22(a)Approve or reject components, products

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Velocity Pharma LLC

8
DateClassificationOfficeProject area
October 23, 2020VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 7, 2019VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
May 18, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 17, 2014NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
January 11, 2013OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 8 other inspections on the company page
Other documents for Velocity Pharma LLC
  • FDA Inspection 1131767 - 2020-10-23
  • FDA Inspection 1092199 - 2019-06-07
  • FDA Inspection 972342 - 2016-05-18
  • FDA Inspection 864122 - 2014-01-17
  • FDA Inspection 813447 - 2013-01-11

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Contact
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