FDA 483 - Strem Chemicals, Inc. - July 30, 2025

During an FDA inspection conducted from July 21-30, 2025, Strem Chemicals, Incorporated, an API manufacturer in Newburyport, MA, received a Form 483 detailing six significant observations related to manufacturing regulations. Key issues included the absence of a documented, ongoing stability testing program for an API, resulting in the release of batches without current supporting data for their retest dates. The company also failed to thoroughly investigate unexplained discrepancies, such as out-of-specification (OOS) assay and impurity results, often dismissing them as 'bad injections' or attributing them to temperature without adequate scientific justification or root cause determination. Additional observations highlighted the failure to qualify critical equipment, specifically a refrigerator used for API storage, which was monitored with an unqualified device. Laboratory control records were found incomplete, with an analyst observed omitting initial test results. Environmental conditions during production were inadequately controlled, lacking documented temperature specifications, and master production records were missing significant information like specific production areas. Strem Chemicals is expected to promptly address these deficiencies by implementing comprehensive corrective and preventive actions to ensure compliance with good manufacturing practices and prevent recurrence.