Wound dressing firm warned for design, environmental control issues

Regulatory NewsRegulatory News | 02 November 2021 |  By 

An Ohio firm that is both an own-label distributor and specification developer of sterile wound dressings received a warning letter from the US Food and Drug Administration (FDA) for ongoing problems including a lack of medical device reporting procedures, design control issues, and lack of document and environmental control, among others.
CellEra LLC, which distributes wound dressings with drugs such as silver, petrolatum and collagen, received the 20 October warning letter after an inspection that took place in late June to early July 2021. However, this inspection followed a May 2019 inspection that resulted in several inspectional observations being recorded on an FDA form 483.
The issues found in 2019 and discussed in a meeting in January 2020 between CellEra and FDA officials went largely uncorrected, according to the warning letter from the Office of Medical Device and Radiological Health that FDA released Tuesday. “This is a repeated issue from the Form FDA 483 issued on May 30, 2019 and discussed during the January 14, 2020 Regulatory Meeting,” noted FDA for each substantive deficiency cited in the warning letter.  
Regarding the lack of written medical device reporting (MDR) procedures, FDA observed that “your firm has not established procedures for timely and effective identification, communication, and evaluation of reportable events; a standardized review process for determining when an event meets reportability criteria; timely submission of MDRs to the FDA; or for compliance with the applicable documentation and recordkeeping requirements.”
CellEra had informed FDA that it had a plan to develop MDR procedures but had not set a date to do so by the time the warning letter was issued.
CellEra had neither implemented or documented a corrective and preventive action (CAPA) plan following the 2019 inspection, noted FDA. At that time, the agency found several problems with the instructions for use (IFU) for CellEra dressings, including improper use of the term “antimicrobial,” claims about the action of a silver-impregnated calcium alginate dressing, and wound cleansing instructions.
During the 2021 inspection, updated IFUs had not been rolled out. CellEra emailed FDA an updated IFU for the silver-impregnated calcium alginate dressings at the end of July 2021, which was not sufficient, said the agency.
“However, you have not provided objective evidence that this new IFU has been approved, the date when the IFU will be included with Vitále Silver Calcium Alginate Dressings, your plan to address the devices currently on the market or ready for distribution that contain an IFU with language beyond what was originally cleared by the Agency under [redacted],” according to the letter. “Further, your response did not address initiating a CAPA(s) for the above IFU changes.”
FDA inspectors also found in 2019 that the firm had a lack of design controls for its devices, a problem that was discussed in the January 2020 regulator meeting and not adequately addressed in subsequent communication from CellEra. Specifically, neither design control procedures nor a design history file had been established by the firm.
The letter cited specific design changes that were made without documentation, including IFU changes, changes to sterilization methods, and shifting of shelf life and storage requirements for some products. Again, CellEra’s proposed response to the deficiencies was deemed inadequate by the agency, in part because the proposed process did not allow for documentation of validation, verification, or review of the design change.
The design changes were unilateral changes made by the contract manufacturer of silver-impregnated calcium alginate products, and were made “without your firm’s knowledge or approval,” according to the warning letter. The firm lacked appropriate agreements with contract manufacturers to ensure that such changes would not affect product quality, noted FDA. This issue had persisted since 2019 and remained unaddressed.
The warning letter also cites CellEra’s lack of acceptance procedures to verify product conformity, lack of document control procedures, and lack of a complaint procedure. “For example, your firm receives oral complaints, but no record is made. Complaints received via your firm’s website are maintained in email format without any indication of evaluation by your firm,” wrote FDA.
Finally, CellEra lacks adequate environmental controls to ensure its products are protected from temperature and humidity excursions that might affect product quality, according to the warning letter.
FDA warned CellEra that it might be denied requests for Certification to Foreign Governments (CFGs) and that premarket approval applications for class III medical devices might not be approved if it does not address the deficiencies found by inspectors. The firm had 15 days to respond to the warning letter.
FDA warning letter


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