FDA Calls Out Pennsylvania Manufacturer for Equipment Maintenance
The FDA hit Pennsylvania drugmaker Bio-Pharm with a Form 483 after an agency inspection in January revealed poor equipment maintenance and quality controls.
The investigator found that the company’s Levittown, Pennsylvania facility lacked written procedures for production controls meant to assure its manufactured products meet their expected identity, strength, quality and purity requirements, according to the agency’s Form 483. Specifically, the company did not finish installing and qualifying equipment such as a bottle unscrambler and packaging system needed to produce certain ANDA drugs.
The facility also had deficient methods for cleaning and maintaining equipment used in manufacturing, such as a tank and mixer used to produce certain drugs.