# FDA 483 - SCHOTT Pharma AG & Co. KGaA - August 14, 2019

Source: https://www.globalkeysolutions.net/records/483/schott-pharma-ag-co-kgaa/8b98efe4-7166-4eef-afa5-48a2504e0152

> FDA 483 for SCHOTT Pharma AG & Co. KGaA on August 14, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SCHOTT Pharma AG & Co. KGaA
- Inspection Date: 2019-08-14
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: SCHOTT AG, a medical device manufacturer in Mainz, Germany, received a Form FDA 483 with five observations following an inspection. The firm was cited for deficiencies including an unvalidated fiber gluing process, inadequate complaint file maintenance lacking MDR reporting evaluations, and insufficient documentation of corrective and preventive actions. Additionally, incomplete device history records and undocumented measuring equipment for incoming acceptance activities were noted, indicating a need for improved quality system compliance.

## Related Officers

- [James R. Montero](https://www.globalkeysolutions.net/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.globalkeysolutions.net/companies/schott-pharma-ag-co-kgaa/aef623fb-2d06-4b9d-acd4-f69945e61890

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd