Catalent Pharma Solutions Limited, Swindon, United Kingdom – FDA Inspections

Inspection records and compliance data for Catalent Pharma Solutions Limited in Swindon. 10 FDA inspections on record, 3 Form 483s, last inspected October 10, 2024.

Company Profile

This profile covers Catalent Pharma Solutions Limited based in Swindon, United Kingdom.

FDA Inspection History

FDA inspections: 10
OAI: 0
VAI: 8
NAI: 1
Unclassified: 1
Form 483s: 3
Warning letters: 0

First inspected November 18, 2011. Last inspected October 10, 2024.

Most cited issue areas

Extent of discrepancy, failure investigations1 inspection
No written record of investigation1 inspection
Procedures not in writing, fully followed1 inspection

FDA inspections (10)

Date	Result	FDA center(s)	Insp. #
October 10, 2024	VAI	Human Drugs · Drug Quality Assurance	1267053
June 15, 2023	VAI	Human Drugs · Drug Quality Assurance	1261182
February 20, 2020	VAI	Human Drugs · Drug Quality Assurance	1141164
August 23, 2018	Not classified	Human Drugs	1065786
July 26, 2018	VAI	Biologics · Vaccines and Allergenic Products	1064287
April 20, 2018	VAI	Human Drugs · New Drug Evaluation	1048918
September 15, 2016	NAI	Human Drugs · Drug Quality Assurance	1051240
September 6, 2016	VAI	Biologics · Vaccines and Allergenic Products	990487
September 12, 2014	VAI	Human Drugs · Drug Quality Assurance	897773
November 18, 2011	VAI	Human Drugs · Drug Quality Assurance	759277

FDA documents

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

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