FDA Warns Chinese API Manufacturer
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 27 June to China-based Zhuhai United Laboratories Co. for significant deviations from CGMP for active pharmaceutical ingredients (API).FDA inspectors found the manufacturer lacks adequate procedures for investigating, and scientific justification to invalidate, out-of-specification (OOS) results.
The firm investigated two OOS assay results and “found no anomalies and only stated that it was possible that the sample glassware was not thoroughly cleaned. Although you did not identify a laboratory error and lacked scientific justification, you invalidated the OOS results. Your firm released both batches based on passing retests,” FDA said, following a five-day inspection last September.
The warning letter also cites the API manufacturer for failing to adequately investigate findings from a February 2015 retrospective review of analytical chromatography data irregularities.
“You did not sufficiently expand the scope of your limited review to a larger data set when you found significant data integrity lapses,” the letter said. “Your investigation was also insufficient because your corrective actions failed to prevent recurrence of major data integrity deviations. For example, our investigators found that your firm deleted the initial chromatographic injection of [redacted] API, batch [redacted], during batch release testing performed several months after the retrospective investigation.”
FDA inspectors also found additional examples of incomplete data relating to Zhuhai’s sterile manufacturing operations evaluated as part of FDA’s pre-approval inspection.
“Our investigators observed that you disabled the electronic audit trail function for your non-viable particle monitoring system for grade A and B areas of workshops [redacted] and [redacted] on at least two days in August 2017 when sterile API was manufactured,” FDA said. “Also, data files containing particle counts had been modified with no indication of who made the changes or what was modified.”
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm612885.htm