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FDA Inspection
•Umedica Laboratories Pvt. Ltd.•March 29, 2024

FDA Inspection 1234389 - Umedica Laboratories Pvt. Ltd. - March 29, 2024

Record Details

This FDA Inspection record concerns Umedica Laboratories Pvt. Ltd., with an inspection on March 29, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Umedica Laboratories Pvt. Ltd.
Inspection Date
March 29, 2024
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Ankur C. Patel
View Company Profile

ID · 51becba8-e46c-4427-a8de-349b242275b3

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1234389
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

1
  1. 21 CFR 211.22(d)Procedures not in writing, fully followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Umedica Laboratories Pvt. Ltd.

3
DateClassificationOfficeProject area
July 5, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 19, 2018NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 9, 2015VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Umedica Laboratories Pvt. Ltd.
  • FDA Inspection 1099875 - 2019-07-05
  • FDA Inspection 1038461 - 2018-01-19
  • FDA Inspection 953634 - 2015-10-09

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