Warning Letters 10/4/2020: Medical Device Adverse Events

Last week, FDA issued a Warning Letter to a drug firm and another to a medical device manufacturer.

Lack of of process validation and cleaning validation were some of the deficiencies mentioned in the drug Warning Letter while the medical device Warning Letter emphasized failure to report adverse events.

For more details on these Warning Letters, see below.

Drug Warning and Untitled Letters

LEC Custom Products, Inc

LEC Custom Products, Inc (Brampton, Ontario) received a Warning Letter on September 24, 2020, based on the outcome of an inspection ending March 6, 2020. The firm manufactures OTC products. FDA notes the firm has ceased manufacturing at the Brampton site and moved to the site in Mississauga. In the words of FDA, “based on repeat observations and your failure to follow through with written commitments to perform various corrective actions at the Brampton and Burlington sites, you do not have adequate executive management oversight and control over the manufacture of drugs,” FDA recommends that the firm hire a qualified consultant to assist them in coming into GMP compliance. The firm was placed on import alert 66-40 on July 14, 2020. Also, FDA notes that some of the OTC products manufactured at the site may be regulated as cosmetics—conditions that cause OTC drugs to be considered adulterated also cause cosmetics to be adulterated. Deficiencies include but are not limited to:

• The first observation seems to address an inadequate water system with problematic microbial content and conductivity. FDA notes the response was inadequate because the firm failed USP requirements and did not commit to routinely testing microbial attributes.  
• The firm lacked a process validation program and did not have ongoing oversight. 
• The firm does not have cleaning validation for equipment shared among multiple products. FDA deemed the firm’s response inadequate because it did not provide enough detail about proposed validation activities. 
• The firm lacked stability data to support expiration dates. There is no stability program and the firm did not know how one would be executed. 
• The firm did not test incoming components and raw materials nor is there a vendor qualification program. Materials are accepted on a CoA and without conducting an identity test. Also, multiple products contain glycerin and the firm does not test for diethylene glycol and ethylene glycol.
• The Quality Unit did not provide adequate oversight of the manufacture of the OTC products. The warning letter a long list of activities that the Quality Unit did not perform. 

Device Warning and Untitled Letters

Batelle Memorial Institute

Batelle Memorial Institute received a Warning Letter on October 7, 2020, regarding their failure to report adverse events as required under the Emergency Use Authorization (EAU) for their Critical Care Decontamination System. After requesting information regarding intake and reporting of adverse events associated with the device, FDA determined the Institute was not in compliance with Authorization H of the EUA, i.e., a lack of processes in place in accordance with 21 CFR Part 803. A lengthy list of shortcomings follows that statement in the Letter itself. 

FDA’s issuance of this warning letter raises the question of whether they selected a large organization to receive this letter with the intent that other manufacturers read this and correct deficiencies they may have in this area. That type of approach is consistent with FDA’s enforcement strategies in the recent past, extending back to the orange juice enforcement under Commissioner Kessler. FDA states that their actions here “… are part of the agency’s ongoing oversight of devices authorized for emergency use to ensure compliance with conditions of the EUA and that the devices remain appropriate for authorization.”

BIMO, GCP and GLP Warning and Untitled Letters

There were none this week.

Compounding Pharmacy/Outsourcing Facilities

There were none this week.