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FDA Cites Optikem for Unsanitary Conditions, Lack of Records
Drugs Inspections and Audits
The FDA hit Optikem with a Form 483 after finding unsanitary conditions and problems with records in an inspection of the firm’s Denver facility.
In the November-December inspection, investigators found the facility’s equipment and utensils were not cleaned or sanitized at appropriate intervals, and the cleaning procedures were not demonstrated to be effective in removing residues or contaminants.
Buildings used for storing raw material were not properly cleaned, with investigators discovering animal matter among the materials. The interior pest control devices were not positioned at each entryway into the building and the production/storage areas.