# FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - September 20, 2024

Source: https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg/36a3eb74-ac85-4c9e-a1a3-1b3247c9639d

> FDA 483 for Vetter Pharma Fertigung GmbH & Co. KG on September 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vetter Pharma Fertigung GmbH & Co. KG
- Inspection Date: 2024-09-20
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG, a drug product manufacturer, revealed significant deficiencies in aseptic processing and quality assurance. Observations included inadequate procedures to prevent microbiological contamination during sterile drug product manufacturing and a failure by Quality Assurance to provide clear conclusions on process validation data. These issues indicate a lack of control over critical manufacturing and quality systems.

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## Related Officers

- [Jiangsong Jiang](https://www.keypedia.com/people/jiangsong-jiang/055e81c4-48a9-423d-b90f-ea0d08df79e1)
- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Richard Ledwidge](https://www.keypedia.com/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)

Company: https://www.keypedia.com/companies/vetter-pharma-fertigung-gmbh-co-kg/6b51041e-37a7-4672-a7e2-c3c871d6231b

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8