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PDM Acondifarma, S.A. de C.V., Ramos Arizpe, Mexico – FDA Inspections

Inspection records and compliance data for PDM Acondifarma, S.A. de C.V. in Ramos Arizpe. 3 FDA inspections on record, 1 Form 483, last inspected September 15, 2022.

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Company Profile

This profile covers PDM Acondifarma, S.A. de C.V. based in Ramos Arizpe, Mexico.

FDA Inspection History

FDA inspections
3
OAI
0
VAI
2
NAI
1
Form 483s
1
Warning letters
0

First inspected January 21, 2009. Last inspected September 15, 2022.

Most cited issue areas

  • Batch production and Batch Control Record Requirements1 inspection
  • Procedure Deviations Recorded and Justified1 inspection
  • Quarantine - actual practice1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
September 15, 2022VAIHuman Drugs · Drug Quality Assurance1181442
December 2, 2016VAIHuman Drugs · Drug Quality Assurance1006378
January 21, 2009NAIHuman Drugs · Drug Quality Assurance571572
FDA documents

No Form 483s, Warning Letters or EIRs on record.

Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

HI-TECH PRODUCTS DE MEXICO S.A. DE C.V.
Orion Corporation, Orion Pharma
Intercos Europe SpA
Asanuma Corporation
PALC
AndersonBrecon Inc
Actavis LLC
Carlsbad Technology, Inc
Universal Packaging Systems, Inc.
Sentry Biopharma Services, Inc.
Company Information

Name

PDM Acondifarma, S.A. de C.V.

FEI Number

3002815808

Address

Av. Industria Automotriz No. 3089, Parque Industrial, Saltillo, Ramos Arizpe, Mexico

Country

Mexico

ID: f274f2a7-b3ec-435a-a061-31be8030987a

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