483 Roundup: Curbell, Carestream, Dynarex, Hard Corporation

The FDA issued Form 483s to four New York-based device manufacturers, primarily for issues with procedures and record-keeping.

Curbell Medical Products: The FDA issued a Form 483 to Curbell Medical Products, citing inadequate procedures for nonconforming products and corrective/preventive actions.

The agency issued the form after a March inspection of Curbell’s Orchard Park, NY, facility. According to the FDA, the company did not include cleaning board switches as part of its rework procedures for non-conforming products even though the rework for one product order included board switch cleaning. Employees conducted rework procedures that were not part of their documented training, according to the form.

The FDA further found that in several cases between October 2014 and March 2017, corrective and preventive actions did not validate that the action did not adversely affect the finished devices. Curbell promised to correct both observations.

Carestream Health: Device manufacturer Carestream Health landed a Form 483 from the FDA due to issues with its testing, validation and complaint procedures.

The agency issued the form following a March inspection of Carestream’s Canandaigua, NY, facility. FDA officials found performance qualification activities for several of the facility’s devices are inadequate, and in many cases were not conducted with the appropriate job element. Similarly, performance qualification activities for the manufacture of those devices took place before the validation plan was approved.

The company also failed to document review and evaluation for corrective actions it took; the records for such actions do not address the potential impact of the problem in future units or document when certain corrections occurred.

The agency also faulted Carestream’s complaint procedures, noting that it did not create complaint tickets for certain events and for others took nearly two months to create them. There were similar problems with records of changes to documents, with inspectors finding document change requests for not always maintained.

Dynarex Corporation: The FDA issued a Form 483 to Dynarex, citing its design validation records, document control procedures and document approval processes.

The agency issued the form following a February/March inspection of the company’s Orangeburg, NY facility. Not only were Dynarex’s design validation records incomplete, the company also lacks a laboratory for analysis and to issue Certificates of Analysis, simply copies and pastes information to their letterhead. The firm lacks established procedures for issuing certificates, according to the form.

Lastly, the firm changed at least one complaint form without completing a Change Authorization Notice, according to the form.

Hard Manufacturing: The FDA hit pediatric device maker Hard Manufacturing for its procedures for design control, complaints and non-conforming products.

Following a February/March inspection of the company’s Buffalo, NY facility, the FDA issued a Form 483. According to inspectors, the company has not implemented its design control procedure as written, and has no design history file.

The agency also found that three of 15 complaints in 2016 were not properly investigated and included either no or insufficient justification for the lack of investigation. Lastly, of 11 non-conformance reports over a 13-month period, several did not document an investigation or the rationale for lack of one.

None of the companies responded to a request for comment.

The four Form 483s can be read here: www.fdanews.com/06-17-17-FourForm483s.pdf. — Zack Budryk