FDA Cites Texas Drugmaker for Cleanroom Deficiencies

Texas drugmaker Isotherapeutics was hit with a Form 483 for multiple violations at its Angleton facility, including problems with its cleanrooms.

The agency’s inspection revealed that the firm didn’t properly recertify a cleanroom to prove its design and construction deterred cross contamination during aseptic processing. Smoke study records were also lacking and the cleanroom’s design was inadequate, the agency said.

The facility’s ISO 7 cleanrooms had counter tops made of a black material that “may be difficult to clean and sanitize,” creating contamination risks, the investigator found. Stools in the cleanrooms were also covered in a black material and could not be properly cleaned and disinfected — and they were not listed in the firm’s environmental monitoring program.