FDA Alleges 'Lack of Control' at Device Firm
An inspection of device firm Pacific Consolidated Industries found conflicting requirements in the company’s design history files, along with several violations of quality system (QS) regulations, according to an FDA warning letter.
The firm’s responses to the FDA’s Form 483 “indicate a lack of control within your firm and a lack of understanding of and/or commitment to the QS regulations,” the letter said.
“Rather than provide documentation of permanent, comprehensive actions, your responses suggest additional violations of the QS regulations,” the December warning letter said. For example, the support bulletins for one product have conflicting statements regarding maintenance frequency.
The firm manufactures portable air separation devices, which purify oxygen from ambient air. These devices are adulterated as they do not conform to current good manufacturing practice requirements, the letter said.
Pacific Consolidated Industries was warned for inadequate complaint procedures, device history records, device design validation, design change procedures and documentation of personnel training.
The company could not be reached for comment by press time.
The warning letter can be seen at www.fda.gov/foi/warning_letters/s6601c.pdf.