A Pennsville, New Jersey API manufacturer drew a Form 483 from the FDA for quality violations at its facility, including failure to reject faulty drug substances and inadequate investigations of discrepancies.
The FDA’s inspection of Siegfried USA, which was held from Nov. 30 to Dec.19, 2018, found one lot of Methadone HCl that was not rejected after it failed purity testing. Normally a white to off-white color, the product had a green tint. The lot was released and distributed despite failing the test.
The agency said the facility also failed to follow its test method or standard operating procedure for reviewing analytical data while it tested a lot of Methadone HCl. “The reviewing analyst failed to verify that the proper sequence was performed, [and] there was no system suitability established for the chromatography run,” it said. The lot’s impurity test led to an out-of-specification finding.