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McNeil AB, Helsingborg, Sweden – FDA Inspections

Inspection records and compliance data for McNeil AB in Helsingborg. 4 FDA inspections on record, 1 Form 483, last inspected June 15, 2022.

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Company Profile

This profile covers McNeil AB based in Helsingborg, Sweden.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
3
NAI
1
Form 483s
1
Warning letters
0

First inspected December 13, 2013. Last inspected June 15, 2022.

Most cited issue areas

  • Computer control of master formula records1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
June 15, 2022VAIHuman Drugs · Drug Quality Assurance1268247
November 27, 2019VAIHuman Drugs · Drug Quality Assurance1124410
May 25, 2018VAIHuman Drugs · Drug Quality Assurance1053240
December 13, 2013NAIHuman Drugs · Drug Quality Assurance860131
FDA documents

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

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ANSTO Nuclear Medicine
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Opella Healthcare International SAS
Visum Pharmaceutical Co Ltd
R-Pharm Germany GmbH
Boehringer Ingelheim Espana S.A.
Company Information

Name

McNeil AB

FEI Number

1000409186

Address

Norrbroplatsen 2, Helsingborg, Sweden

Country

Sweden

ID: 9c06dc92-0eb8-4271-b543-048254a0f580

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