Manufacturer Gets 483 for Not Reviewing Batches
The FDA was not happy that Elite Laboratories’ quality unit failed to validate and review various product batches before distribution, landing the generic drug maker a Form 483.
During a May to June inspection of its Northvale, N.J., facility, investigators discovered certain failings in the company’s quality unit.
For instance, a batch of methadone tablets was released for distribution with a blank quality affairs checklist, which is used to document the review and approval of the batch.
Investigators also found a batch of phentermine tablets rejected due to capped tablets found at the start of the packaging operation. The company’s acceptable quality limits procedure, which is used to determine defects in products, was not able to detect the problem of the capped tablets, the FDA said.
The FDA also discovered that Elite was late in submitting annual reports on some products. A drugmaker must submit an annual product report within 60 days after the anniversary date of its U.S. approval.
The annual report for naltrexone tablets was due on July 25, 2013, but wasn’t submitted until March 25, 2014, said the form that contained 13 observations.
Elite Laboratories did not return a request for comment as of press time.
Why risk a Form 483 or warning letter when it’s so easy to do batch record reviews right? Purchase Mastering Batch Record Review today.