The FDA cited German drug manufacturer Pekana Naturheilmittel for cleaning violations and other problems observed at its Baden-Wurttemberg facility.
In an inspection between May 28 and June 1, the FDA inspector found that the facility had deficiencies in its routine procedures for cleaning drug manufacturing equipment.
The validation study for cleaning manufacturing vats did not include certain parameters, such as how the employees performed the cleaning process, and didn’t include the lots and expiration dates of cleaning agents and water temperature, among other items.
Critical cleaning steps for equipment such as drug filtration equipment and bottling lines were not recorded in books employees used to log the dates and times of equipment cleaning. The records also failed to include lots and expiration dates of cleaning agents and other information, the investigator found.