# FDA 483 - Biologische Heilmittel Heel Gmbh - February 01, 2019

Source: https://www.keypedia.com/records/483/biologische-heilmittel-heel-gmbh/b7b54828-5c7b-4080-be29-c5035213f109

> FDA 483 for Biologische Heilmittel Heel Gmbh on February 01, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biologische Heilmittel Heel Gmbh
- Inspection Date: 2019-02-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Biologische Heilmittel Heel Gmbh, a sterile drug manufacturer in Baden-Baden, Germany, was cited for multiple quality control deficiencies during an FDA inspection. The observations highlight issues with product testing, adherence to established procedures, data integrity, and inadequate documentation of manufacturing processes. These findings indicate a need for significant improvements in the firm's quality management system.

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Company: https://www.keypedia.com/companies/biologische-heilmittel-heel-gmbh/e163fb49-bc67-47e3-9482-f204f12aeb64

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1