Human-Machine Interface Ratted On Apollo Workers Who Fibbed Batch Data
Executive Summary
The US FDA applied laboratory data integrity inspection technique to production floor, leading to warning letter, import alert.
A warning letter the US Food and Drug Administration posted 7 January provides yet another indication that the agency is taking a powerful method for checking on laboratory data integrity and adapting it for use in the production environment.
Data integrity failures related to production equipment identified during a 12-16 August inspection led the agency on 16 December to issue an import alert, followed on 23 December by the warning letter to Apollo Health and Beauty Care Inc., North York, Ontario, Canada.
Shortcomings in process validation and deficiency investigations seen during the inspection also figured into the enforcement response.
In the laboratory, FDA investigators in recent years have been comparing written records against data automatically recorded in the software of analytical equipment such as high-performance liquid chromatography systems.
But at Apollo, the investigator compared written batch record entries against human-machine interface data. The data showed equipment was not operational at the time batch records said it was used, forcing the quality unit to acknowledge to the investigator that the batch record was inaccurate.
Apollo compounded the problem with a 3 September inspection response, in which the company promised merely to investigate any future discrepancies between randomly selected batch records and the human-machine interface data. The FDA expected Apollo to do much more: find the root cause of the discrepancies, look for similar discrepancies in other operational areas, and deal with the management failures that allowed the data integrity failures to occur.
The FDA noted some other investigation failures as well. For example, after tracing particles in one product lot to a broken belt on a filling line, Apollo simply rejected some units of the lot, failing to consider whether other batches previously filled on the line might have been affected, and failing to update the preventative maintenance plan to prevent recurrence.
Located about an hour and a half by delivery truck from the Rainbow International Bridge, which crosses the US border just below Niagara Falls, Apollo will not be able to resume US exports until it satisfies the FDA that it has remediated its manufacturing process.
The warning letter says Apollo contract-manufactures over-the-counter drugs, some of them labeled for use by children.
Apollo’s website says the company manufactures and distributes personal care products for companies like [Wal-Mart Stores Inc.], Target Corp. and Loblaws in the US, Mexico, Central and South America and the Middle East.