FDA Cites Optikem for Unsanitary Conditions, Lack of Records

The FDA hit Optikem with a Form 483 after the agency’s investigator observed 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. Investigators also observed cats in the immediate vicinity of the property’s outer limits and damage to dock doors, ceilings and walls where pests could potentially enter.

The agency also faulted the facility for its specifications, sampling plans and test procedures. Investigators found the firm had no raw material or finished product specifications, sampling of finished product or sampling of raw/in process materials, or raw material and finished product testing requirements.

In addition, the firm also had no production records for drug manufacturing operations or logs of cleaning for any operations except its lens cleaning solution. The facility also failed to include any maintenance records in major manufacturing equipment log books.