The QMN Weekly Bulletin

FDA Calls Out Pennsylvania Manufacturer for Equipment Maintenance

June 8, 2018

The FDA hit Pennsylvania drugmaker Bio-Pharm with a Form 483 after an agency inspection in January revealed poor equipment maintenance and quality control issues.

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.

The firm did not establish a risk matrix for its cleaning validation study detailing its worst case product in terms of toxicity and difficulty to clean.

“There is no record included with the cleaning validation study to show that any drug product was manufactured, using the equipment addressed in the cleaning validation, prior to execution of the cleaning validation protocol and study,” the agency said.

In addition, the firm did not perform any risk assessment for its swab sampling points or record the amount of cleaning solutions it used in certain tanks.

The agency also noted problems with the firm’s quality control unit. After performing a quality review of certain equipment log books, it became evident that the firm did not ensure that it spent the minimum required time performing a cleaning procedure for liquid manufacturing equipment.

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