The QMN Weekly Bulletin

Warning Letter Roundup: FDA Warns Three Firms Over GMPs, Validations

May 26, 2017

The FDA issued warnings to three device manufacturers for failures in GMPs, validations, MDRs, and other quality-related areas.

The FDA warned International Medsurg Connection over the production of adulterated hypodermic syringes at its Schaumburg, IL, facility. The agency issued a Form 483 following an inspection conducted from August 16 through September 16, 2016, but found the company’s response inadequate.

Among other GMP failures, the facility lacked proper procedures to ensure the syringes met specifications. The firm also released syringes without testing using an appropriate sample size.

In addition, Medsurg lacked adequate requirements for suppliers and contactors. For example, it did not include a sterilization requirement.

The agency also noted the company’s CAPA procedure failed to ensure that corrective or preventive actions were effective and did not adversely affect the finished device. In addition, the CAPAs did not include evidence for their closure, as required by the firm’s CAPA procedure.

The facility also lacked an MDR procedure.

Oxford Performance Materials: Oxford Performance Materials drew a warning following a March/April inspection of its South Windsor, Conn., facility. The company failed to validate cleaning of several of its implants, according to the FDA letter, despite receiving at least one complaint regarding a contaminated cranial implant.

The facility also lacked established procedures for removal of manufacturing material in a way that did not compromise device quality, according to the letter. At least one product’s packaging was found ripped open and taped shut with packing tape, and inspectors found the material was accepted without any record of inspection. The material in question came into direct contact with the cranial implants during the cleaning process.

Officials also found the company did not properly monitor environmental conditions that could impact product quality, according to the letter, and the firm lacked established schedules for adjustment, cleaning and maintenance of equipment.

The FDA acknowledged that the firm had hired a third party to perform environmental monitoring of the facility and said the agency would like to see the final report and sampling plan “to ensure they address all areas of concern.”

Vidco: The FDA cited Vidco for validation of changes and other deviations following a January inspection of its Beaverton, Ore., facility.

According to inspectors, the firm failed to develop procedures for validating device design to ensure its products conformed to the intended use. The company approved four change notices for its products without validation, including altering software in its monitoring devices to add internal speakers to provide alarms.

The three other change notices, the facility failed to document that devices used in validation were initial production units or their equivalent. Furthermore, the firm’s quality manual specified the use of prototype devices for design validation, whereas regulations require the use of initial production units, lots, or batches or their equivalents for design validation.

The firm also failed to establish CAPA procedures. Almost a quarter of the CAPAs the firm conducted since 2014 did not document the effectiveness of the actions taken.

The company pledged to establish a CAPA procedure that requires verifying effectiveness, but did not provide sufficient detail for how it plans to implement the procedures, the agency said.

Remember, you have only 15 days to respond to a 483. Most of that time will go toward bringing your CAPA program into compliance. Don't waste a second trying to figure out how to communicate those plans in a way that will convince the FDA you are focused on improvement and committed to quality. Learn from those who have been there. Effective 483 Responses: Focus on CAPA Violations will be your go-to manual.

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