Contract manufacturer Neolpharma received an FDA Form 483 at its Puerto Rican facility for quality and production failures following a June 2 to 18 inspection.
The Form 483 says there are no written procedures for production and process controls. The firm’s quality unit rejected more than 10 lots of Detrol LA (tolteridone tartrate) due to failed dissolution tests, but the FDA inspector observed that there was no assurance that the company accurately identified the source of process variability and the root cause for the failures.
In addition, drug products are not stored under appropriate humidity conditions, even though labels clearly indicate humidity requirements.
The company also failed to implement adequate corrective actions regarding recurrent pests in the manufacturing area. The 483 notes five examples that include lizards, iguanas, ants and small flying insects within the manufacturing areas.
The 483 notes that from July 2013 to December 2014, the microbiology lab reported at least 26 instances of out-of-action limits results during cleaning validation studies. According to the company’s investigations, most of the events were attributed to human error.
The Puerto Rico facility makes liquid and solid dosage forms, capsules and pearls.
Neolpharma did not respond to requests for comments.
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