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FDA Inspection
•AVEVA Drug Delivery Systems, Inc.•July 26, 2019

AVEVA Drug Delivery Systems, Inc. – FDA Inspection, Jul 26, 2019

Record Details

This FDA Inspection record concerns AVEVA Drug Delivery Systems, Inc., with an inspection on July 26, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
AVEVA Drug Delivery Systems, Inc.
Inspection Date
July 26, 2019
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Dipti Kalra (Company Rep)
  • Haley H. Seymour (Company Rep)
  • Jennifer Lalama (FDA Associated Person)
  • Richard A. Lyght (Issuing Officer)
  • Youmin Wang (Company Rep)
View Company Profile

ID · d170ba16-0462-441b-a734-bb650d5d414a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1097807
FDA center
Human Drugs
Project area
Generic Drug Evaluation
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 211.160(b)(3)Acceptance of drug products
  2. 21 CFR 211.192Investigations of discrepancies, failures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of AVEVA Drug Delivery Systems, Inc.

6
DateClassificationOfficeProject area
August 14, 2026Not classifiedFlorida District OfficeDrug Quality Assurance
September 1, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 27, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 11, 2014VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 28, 2011VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 6 other inspections on the company page
Other documents for AVEVA Drug Delivery Systems, Inc.
  • FDA Inspection 1330946 - 2026-08-14
  • FDA Inspection 1216787 - 2023-09-01
  • FDA Inspection 1049851 - 2018-04-27
  • FDA Inspection 879211 - 2014-04-11
  • FDA Inspection 742495 - 2011-09-28

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