Medical Device Warning Letter Round-Up: FDA Won’t Take No For an Answer
This latest round of warning letters is all about pushback.
The FDA is not happy with the responses it received from Acme Monaco Corp., a New Britain, Connecticut-based manufacturer of medical guardwires for cardiovascular and urologic use.
In an April 28 letter, the agency reminds the company that an earlier FDA inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Parts 820.
Mar Cor Purification in Minnesota was hit with an April 17 letter that found fault with, among other things, its CAPA, complaint handling, and document control. In addition, the FDA said Mar Cor’s March responses were inadequate. Mar Cor manufactures water purificaiton systems used to diagnose diseases.
Heading over to Wisconsin, a March FDA letter hit Cytophill Inc, a manufacturer or synthetic bone graft material, bone void fillers, and an intranasal splint, for a number of shortcomings.
In addition to hitting the firm for below mark CAPA, process and storage controls, FDA warned it about failure to:
- Control environmental conditions
- Validate a process whose results cannot be verified by subsequent inspection and test
- Establish procedures to handle changes to a specification.
As many former FDA inspectors have told us over the years, a bad response to a warning letter is a really bad idea. Most FDA inspectors will work with you if they believe you are acting in good faith to correct the problem. It’s not unlike the IRS. If you call them and work out a lenient, reasonable payment plan, everything’s fine. Unless you miss a payment or two without giving them a heads-up. That’s when the trouble usually begins.