FDA 483 - Coastal Meds, LLC - April 06, 2018

The FDA Form 483 details significant deficiencies observed during an inspection of an outsourcing facility.

**Environmental Monitoring and Aseptic Processing:** * Environmental monitoring (EM) is inadequate, lacking samples in high-risk areas like the material pass-through box. * Fingertip and surface samples are taken improperly (e.g., after sanitization, on wet surfaces). * Pressure differential data is not reviewed, saved, or investigated, leading to unaddressed excursions (e.g., on 12/5/2017, impacting METHYLCOBALAMIN, Lot MC/120517). * Aseptic attire is deficient, as personnel do not wear goggles, exposing skin. * Pressure gauges for monitoring differentials are not calibrated.

**Laboratory Controls and Product Quality:** * Visual inspection of finished injectable products is inadequate due to lack of contrasting backgrounds and sufficient light, potentially missing quality issues. * Finished product release testing does not include content for preservatives used in all injectable drug products. * Sterilization process validation is deficient; the sterilizing method is not compliant with manufacturer's test methods or independently validated. * Media fill records lack critical information, including media preparation, materials used, filling process, and number of vials.

**Facility and Equipment Maintenance:** * Building construction materials within the ISO 7 cleanroom are unsuitable for cleaning solutions,