Mississippi Devicemaker Repeated 2012 Violations
A Jackson, Miss., devicemaker received a 16-count Form 483 from the FDA’s Detroit district office after an inspection found major problems with the company’s risk analysis, testing procedures and employee training. Some of the observations were repeated from a 2012 inspection.
According to the 483, Midbrook didn’t properly warn customers of the risks involved in changing cleaning procedures for its Class II Tempest Washer/Disinfector, even though changing the enzymatic cleaner could cause the device to fail if not done properly.
In addition, Midbrook didn’t have design change procedures, and the design history file didn’t demonstrate compliance with federal regulations for solvent extraction processes. Both of these problems were also noted in 2012, as was an observation concerning lack of training for internal audits. Internal audits were also a problem, with the last audit dating to January 2013 and no set audit procedures.
Another repeat observation related to a lack of device history records to show finished device acceptance. There were no records on final electrical testing before the devices were released, the Form 483 states.
The investigator said the company hadn’t maintained records of several field corrections that weren’t required to be reported to the FDA, and didn’t justify why the actions weren’t reported. And, in another repeat observation, Midbrook had no formal complaint handling procedures, the form shows.
Midbrook also failed to fully document or investigate several reports of noncompliant products, and the company’s procedures for investigating noncompliances were incomplete. For example, the company didn’t require retesting or evaluation of reworked products.
The company wasn’t using its CAPA procedures and was unable to prove it had analyzed data to identify causes of nonconforming products between January 2013 and Dec. 2, 2014, the form notes. Further, no corrective action requests were initiated for the 13 observations found after the FDA’s 2012 inspection.
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