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FDA Inspection
•Pharmaffiliates Analytics & Synthetics Pvt., Ltd.•July 5, 2024

FDA Inspection 1243287 - Pharmaffiliates Analytics & Synthetics Pvt., Ltd. - July 05, 2024

Record Details

This FDA Inspection record concerns Pharmaffiliates Analytics & Synthetics Pvt., Ltd., with an inspection on July 5, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Pharmaffiliates Analytics & Synthetics Pvt., Ltd.
Inspection Date
July 5, 2024
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Guerlain Ulysse (FDA Associated Person)
View Company Profile

ID · 3d45d4e6-b143-46a2-bcc0-90156040cdf7

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1243287
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

2
  1. 21 CFR 211.160(a)Lab controls established, including changes
  2. 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 Pharmaffiliates Analytics & Synthetics Pvt., Ltd.

1
DateClassificationOfficeProject area
July 31, 2015VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Pharmaffiliates Analytics & Synthetics Pvt., Ltd.
  • FDA Inspection 938312 - 2015-07-31

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