The FDA flagged device firms in the U.S., Germany, the United Kingdom, the Czech republic, and India for a range of issues, including MDR reports, CAPA failures and other GMP issues.
BEKA Hospitec: The FDA cited a German medical device manufacturer for noncompliance issues related to MDR reports, complaint handling, as well as device master records and history records.
The agency’s Form 483 report issued after inspecting the facility from Jan. 30 to Feb. 2 observed that MDR and complaint reports were not completed after several events that called for them, including the firm’s Carlo lift lowering onto a patient’s face leaving a bruise, a lift bar “breaking at the swivel connection point just after the patient was transferred to a bed,” and a lift shaft bolt “shearing while a patient was in the lift, causing the patient to fall and the carry bar to fall on the patient’s chest.”
The investigator also observed that BEKA Hospitec had not established design validation protocols and acceptance criteria before performing validation activities on its Sina Comfort Shower Trolley.
Research Instruments: UK-based Research Instruments drew a Form 483 from the FDA over documentation, device history maintenance and procedural issues.
The manufacturer failed to identify products’ acceptance status and did not conduct effectiveness reviews of the facility’s quality system, the agency found in an inspection in April.
Certain management reviews were not conducted in 2015, 2016 and 2017, and senior management officials were not present during at least one management review, the agency said.
Embrace Health Care: Embrace Health Care lacked adequate complaint handling, product acceptance, CAPA or written MDR procedures when the FDA inspected its New Hampshire facility in July, according to a Form 483 report.
The firm had no procedures for analyzing sources of quality data, investigating the cause of nonconformities, identifying needed actions to prevent recurrences of nonconformities, among other CAPA deficiencies.
The FDA investigator also noted the facility lacked an adequate quality system and procedures, such as those for internal audits.
Healthy Spirit: An FDA inspection of Healthy Spirit’s manufacturing facility in Maryland revealed 14 nonconformities related to required procedures, documentation, complaint handling, management reviews, and employee training.
The investigator inspected the facility from May into July and found that the firm had not established procedures for finalizing acceptance, designing or maintaining device history records of its EasyRest Adjustable Sleep System. The facility also lacked instructions for installation and inspection and test procedures for the system, according to the Form 483.
The firm also lacked procedures for device labeling and Unique Device Identification, and an explanation for why certain customer complaints were not required to be documented.
Documentation of damaged mattresses received since 2013 and CAPA actions initiated to address supplier nonconformities was not provided. The firm was also unable to produce supplier selection and evaluation records.
Healthy Spirit had not documented internal audit reports since 2012 or management reviews of its quality management system since 2013, the agency said.
Olympus Medical Products Czech: The FDA found inadequate production monitoring, CAPAs and equipment inspection procedures in an April inspection of the Olympus Medical Products Czech facility in the Czech Republic.
A Form 483 issued following the inspection noted the firm had only performed visual inspections on its equipment, with no assurance that visual inspection was adequate to ensure the product is made to the correct specifications.
Read the BEKA Hospitec Form 483 here: www.fdanews.com/10-18-17-bekahospitecgmbh483.pdf.
Read the Research Instruments Form 483 here: www.fdanews.com/10-18-17-researchinstrumentsltd483.pdf.
Read the Embrace Health Care Form 483 here: www.fdanews.com/10-18-17-embracehealthcarellc483.pdf.
Read the Healthy Spirit Form 483 here: www.fdanews.com/10-19-17-healthyspiritllc483.pdf.
Read the Olympus Medical Products Form 483 here: www.fdanews.com/10-19-17-olympusmedicalproductsczech483.pdf.
Effective 483 Responses
A response to a Form 483 is not a routine or informal communication and should be given the same attention and care you would give to defending your company from a federal indictment—because that’s what a 483 actually is.
The response “needs to be treated with the same level of sincerity, effectiveness, clarity as any situation would be if you were involved in any other kind of law enforcement setting,” says Gordon Richman, vice president and regulatory compliance counsel to Danaher Diagnostics Platform.
The purpose of the response is to make your case to the FDA: convince the agency that you take its warnings seriously, are committed to improvement and have a solid, detailed plan for fixing your deficiencies. Unfortunately, the FDA provides no guidance on what it expects to see in a response. Even worse, it gives you only 15 days to deliver it.
It also becomes part of the agency’s official administrative record, and it’s really the first opportunity for the company to get its side of the story in that record. FDA investigators are generally very good at what they do, Richman says, but there can be misunderstandings and miscommunications.
“They don’t always get it right, and there’s usually some additional information the [company] thinks of or obtains after the inspection is over that provides further clarity to the story,” he says. “So it’s important for the company to put its foundation in place in that record.”
And it’s not just what gets put on paper that’s important. “The actions that the company takes, the meeting of its commitments, the thoroughness of its review and assessment to other activities that may be related are really important,” Richman says.
The most important step in developing a response is analyzing the observations in the 483.
What is the investigator saying? What was the underlying concern? What did interactions with the investigator during the inspection add to understanding the observation?
Excerpted from the FDAnews book: Effective 483 Responses: Focus on CAPA Violations.