The FDA cited four devicemakers for problems with their complaint procedures, change controls and quality oversight, among other deficiencies.
PF Consumer Healthcare: Failure to establish procedures for receiving, reviewing and evaluating complaints as well as failure to report complaints and other quality management issues landed Pfizer subsidiary PF Consumer Healthcare a 10-observation, 17-page FDA form 483 following a Feb. 25 to April 4 inspection of its manufacturing plant in Atlanta, Georgia.
FDA inspectors found that complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated or investigated. Between Jan. 1, 2018 and Feb. 28, 2019, there were roughly 4,622 adverse events reported associated with the Thermacare pain product, and 1,199 product complaints and/or adverse events were not investigated. Only 94 of the complaints were filed with the FDA as MDR reports.
Three serious adverse events, one involving an alleged death, and others resulting in second- and third-degree burns were not forwarded to the product quality complaint group, and investigations into the events weren’t conducted, the agency said.
According to the firm’s business process manual, adverse events sent to the product quality complaint group could be canceled if there is “an allegation of a burn without a quality defect noted,” the 483 says. The rationale was that burns without an allegation of a quality defect are considered adverse events only and should follow standard practice, which is to log them as complaints only if the safety division doesn’t request a follow-up for an investigation.
At least 11 adverse events involving burns, some of which were third-degree burns, were sent from the safety group to the product quality group and were canceled based on this policy.
During the same period that the FDA investigators were visiting the plant, Pfizer issued an April 26, 2019 press release recalling one lot of its Thermacare back pain heatwraps due to out of specification results for high cell temperatures. Pfizer said units were distributed nationwide and in Puerto Rico from June 2017 through March 2018, and it was removing the product from stores.
The 483 also cites the firm for failing to implement corrective and preventive action SOPs. For example, the firm’s procedures for the Thermacare site quality review team require periodic review of quality data sources as well as historical records to identify trends in complaint data. Nearly twice the normal number of complaints were reviewed, but an investigation was not carried out.
The FDA said the firm failed to follow correct test methods and failed to list maximum temperatures measured during testing, and it didn’t properly validate the test.
The investigator listed a litany of other quality problems, including failure to establish procedures for quality audits, failure to document in-process inspections or other verification activities, and failure to establish adequate document control procedures.
Bio-Med Diagnostics: Lax change control procedures and document control issues were uncovered during an April 16-19 FDA inspection of Bio-Med Diagnostics’ White City, Oregon facility.
Documentation to show that preventive actions were implemented to address gaps in training was lacking for the company’s InTray GC, a Class II in vitro diagnostic device for detecting gonorrhea.
Bio-Med implemented a new software system to control all aspects of its product inventory, incoming acceptance activities, nonconforming product and final release. FDA investigators said the firm failed to follow its change control procedures when implementing the new software, and it didn’t have a change control report or validation report documenting the change.
The agency cited the firm for inadequate validation procedures because it failed to validate equipment used to sterilize its products.
Document control procedures were also found lacking in that the clinical microbiology catalog and InTry GC flyer were not reviewed and approved according to the company’s SOPs. Obsolete documents were also being used, the agency said.
LPE Holdings: Failure to develop procedures for medical device reporting or for receiving, reviewing and evaluating complaints were among the quality system failures FDA inspectors found during an April 15-17 inspection of LPE Holdings’ Woodland, Wash. manufacturing facility.
The firm manufactures patient loading utility systems, Class II devices for loading patients onto airplanes. At least four complaints were still open at the time of the inspection.
The procedure didn’t require all service records to be evaluated for potential complaints, and the firm had not conducted the procedure since 2016.
CAPA procedures were also not adequately defined or implemented and they didn’t include requirements for documenting that CAPA actions were verified or validated.
Diamond Orthopedic: The FDA hit medical equipment manufacturer Diamond Orthopedic with a Form 483 for multiple violations at its Charlotte facility, including deficient supplier contracts and poor oversight of the quality system.
During a March 25-April 5 inspection, the investigator noted 11 observations. For example, the firm neglected to determine if a complaint about a device failure warranted reporting to the agency as an adverse event — and its complaint record didn’t justify the decision not to submit an MDR.
“The medical device investigation report does not record how the patient’s care was affected and it does not include comments from the doctor or medical professional that the incident was not a reportable event,” the agency said.
The investigator also found that device label review procedures weren’t up to par. For example, a work instruction describing packaging and labeling activities did not instruct the quality operator to compare all label information to the device master record for accuracy and completeness.
The investigator found that the firm didn’t have quality agreements in place with all its critical suppliers. Two of the firm’s seven quality agreements with suppliers, contractors and consultants had deficiencies.
The company’s investigations into nonconforming devices were shoddy, the agency said. Ten packages of medical devices returned by a contract manufacturer were not investigated to determine the root causes of nonconformance. Furthermore, no procedures were in place to ensure nonconforming devices were evaluated quickly.
Additionally, the firm didn’t properly calibrate a measuring device. Records from the caliper’s manufacturer did not include a calibration date, making it impossible for the firm to know when to perform calibration.
Diamond also lacked adequate procedures for identifying quality system deficiencies and executing corrective and prevention actions.
Read the PF Consumer Healthcare Form 483 here: www.fdanews.com/08-15-19-pdconsumerhealthcare1llc483.pdf.
Read the Bio-Med Diagnostics Form 483 here: www.fdanews.com/08-15-19-biomeddiagnosticsinc483.pdf.
Read the LPE Holdings Form 483 here: www.fdanews.com/08-15-19-lpeholdingsllc483.pdf.
Read the Diamond Orthopedic Form 483 here: www.fdanews.com/08-15-19-diamondorthopedic483.pdf.