FDA 483 - allphamed PHARBIL Arzneimittel GmbH - July 12, 2019

An FDA inspection of allphamed PHARBIL Arzneimittel GmbH in Gottingen, Germany, revealed multiple deficiencies in their manufacturing operations. The firm was cited for inadequate batch production and laboratory records, insufficient laboratory controls for visual tests, and failure to follow written production procedures. Other issues included a lack of equipment cleaning records, inadequate employee training on SOPs, and a quality control unit that did not fully adhere to its responsibilities.