# FDA EIR - Eurofins PHAST GmbH - July 17, 2018

Source: https://www.keypedia.com/records/eir/eurofins-phast-gmbh/8ef51758-796e-4005-b1d4-2cb496bc1888

> FDA EIR for Eurofins PHAST GmbH on July 17, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Eurofins PHAST GmbH
- Inspection Date: 2018-07-17
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA surveillance inspection of PHAST GmbH, a contract testing facility in Homburg, Germany, was conducted from July 16-17, 2018. The inspection, performed under the drug manufacturing regulatory framework, focused on the firm's Quality and Laboratory Control Systems, as it provides services for various U.S.-marketed drug dosage forms. Notably, this inspection concluded without issuing a Form FDA 483 (Inspectional Observations), indicating no official regulatory violations were documented. However, two significant issues were verbally discussed with management. First, the firm's Out-of-Specification (OOS) procedure requires strengthening, as it currently lacks a defined limit for retesting when laboratory errors are identified, raising concerns about 'testing into compliance.' Second, improvements are needed in testing documentation; a deviation from an approved High-Performance Liquid Chromatography (HPLC) method was not referenced in the relevant write-up, and a required column equilibration step was not documented. PHAST GmbH was reminded of its ongoing responsibility to detect and correct any manufacturing practice deviations, irrespective of formal inspection findings. The firm was recently acquired by Eurofins in 2018.

## Related Officers

- [company_representative](https://www.keypedia.com/people/christoph-pfahler/0d68bfef-5d52-42a2-9e27-4ff8b6b02004)
- [Consumer Safety Officer (Drug Specialist)](https://www.keypedia.com/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)
- [company_representative](https://www.keypedia.com/people/johannes-kramer/95c11b40-b592-4657-914a-4572763567d2)
- [company_representative](https://www.keypedia.com/people/verena-muller/9976f9ef-88f1-423c-95d6-8031fed7f204)
- [recipient](https://www.keypedia.com/people/pascal-van-de-veire/c08b4ef5-53bb-4394-9b87-4382d1c863d0)

Company: https://www.keypedia.com/companies/eurofins-phast-gmbh/be1c1be5-f239-4b3c-a3fd-38d19dd5766d

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64