The FDA cited to four devicemakers for a range nonconformances including problems with design controls.
HLPR: The FDA issued a Form 483 to HLPR saying the device contract manufacturer did not properly validate its processes or calibrate equipment.
The agency issued the form following a November/December 2017 inspection of the company’s Hamel, Minnesota facility. A process used for the company’s External Pulse Generator Disposable Pouch was not properly validated, according to the FDA, and a required test was not being performed.
The company also did not properly calibrate equipment used in the production of the disposable pouch, despite a provision in the company procedures stating that all equipment used for accepting product must be maintained and calibrated routinely and prior to use.
The facility lacked adequate device history records for the disposable pouch. The company also failed to maintain training records for at least two operators who assembled pouches in late 2014 and early 2015.
Modal Manufacturing: Modal Manufacturing drew a Form 483 from the FDA for problems with its procedures for ensuring all products it received conformed to specification and for inadequate design risk analysis.
The FDA issued the form following a December 2017 inspection of its Palm Beach Gardens, Florida facility. Investigators found that four of the facility’s suppliers did not have any on-site audits as required by the company’s standard operating procedures, and it did it complete a required desk audit at its instrument supplier facilities.
Investigators also found that the company conducted several processes that were not properly validated. In addition, the company’s risk analyses for its Hip Total Hip System and Knee Systems did not properly include class 2 instruments in its process failure mode and effects analysis.
Spectra: The FDA cited Spectra Therapy for deficiencies in design control, medical device reporting and CAPA procedures.
The agency issued a Form 483 following a November/December inspection of the device manufacturer’s Troy, Michigan facility. According to investigators, the company designed and developed its Spectra A-100 Impulse Laser Device without design control procedures.
The agency also faulted the facility on its written MDR procedures. The facility lacked written procedures to ensure timely identification and evaluation of events that potentially require MDRs, or a standardized review process for determining which events are reportable, or for timely transmission of MDRs.
The facility also had not established a purchasing control procedure setting out requirements suppliers, contractors and consultants must meet, and had no established procedure for acceptance of incoming product.
TriMed: The FDA cited TriMed for numerous deficiencies such as faulty design control, inadequate design change procedures and incomplete risk analysis.
The agency’s November 2017 inspection of the firm’s Santa Clarita, California facility revealed issues with a design control procedure after the inspector reviewed the design history files for the firm’s Distal Humerus Fixation system (DHFS) and the Nitinol Sterile Staple system (NSSS).
For example, design inputs for the DHFS did not address performance requirements, such as expected product reliability under its stated uses. The sole design verification report only addressed the mechanical strength of the plates, with no records showing that other device aspects were verified.
The firm also had deficient procedures for design changes. A complaint received for a Dorsal Wrist Hook Plate alleged that “a screw went through the dorsal hook plate” and the plate seemed to be manufactured incorrectly. After investigating the complaint, it was determined that the failure was related to an unverified and unapproved design change made to the product that was not validated.
In addition, design changes made to the firm’s Humeral Supracondylar Medial Nail plate were not verified or validated, although the engineering change release lists the parts as “Use”.
In addition, the firm conducted inadequate risk analysis. It initiated corrective and preventative actions to address customer complaints about hex drivers with epoxy melting and coming off after undergoing sterilization at the user’s facilities.
Because the malfunctions risked dropping particles into surgical sites, they were deemed reportable to the FDA as medical device reports. However, the firm’s analysis for the fixation systems failed to document and assess the risks.
The firm also lacked written CAPA or complaint procedures.
Read the HLPR Form 483 here: www.fdanews.com/04-05-18-hlprinc483.pdf.
Read the Modal Manufacturing Form 483 here: www.fdanews.com/04-05-18-modal483.pdf.
Read the Spectra Therapy Form 483 here: www.fdanews.com/04-05-18-spectratherapyllc483.pdf.
Read the TriMed Form 483 here: www.fdanews.com/04-06-18-trimedinc483.pdf. — Zack Budryk and James Miessler
Will the FDA Respond to a 483 Response?
Question: Once we’ve submitted our response, should we expect a response from the FDA and how long does it usually take?
Answer: There’s really no measuring stick for how long it may take to get a response.
Sometimes you won’t get much of a response from the agency. Sometimes it will be months and months and months down the road. And that can mean a number of different things. It could mean the FDA isn’t fully satisfied yet and officials are making decisions about what to do next. It could also mean that your response is just caught up in the agency’s backlog.
You typically will get a response from the FDA at some point if the agency is satisfied, just letting you know that it received and reviewed your responses and considers them adequate.
Sometimes you can get some insight into what might be going on. If you contact your district office and request a copy of the Establishment Inspection Report, but the FDA is unwilling to release it to you, that indicates that the agency considers it an ongoing enforcement matter. The FDA won’t release an EIR until it considers all issues to be closed out.
Excerpted from the FDAnews management report: Effective 483 Responses: Focus on CAPA Violations.