FDA Form 483 for Zimmer Biomet Includes Repeat CAPA Observation
Posted 07 February 2018 | By
Following a 10-day inspection last October, the US Food and Drug Administration (FDA) sent a Form 483 with eight observations to Zimmer Biomet’s Detroit-based manufacturing site. The same site also received a Form 483 following an inspection in December 2016.
The latest Form 483’s first observation, which the agency notes is a repeat observation from inspections in 2011 through 2015, explains the company’s failure to establish procedures for corrective and preventive actions.
The observation deals with the recurrence of the usage of nonconforming Class II hip and Class II/III knee implants found adhered with a bag in which they are held.
In June 2017, the Form 483 says Zimmer received a complaint alleging that "a surgeon opened a femoral implant and found parts of the plastic bag sticking to the implant. The surgeon then cleaned the plastic from the implant and implanted the device in the patient. The investigation into the complaint concluded on 08/24/2017. The investigation details for this complaint concluded that the plastic bag sticking on the implant was the ‘old style poly bag [redacted].’"
But FDA said the "scope of the containment action was not sufficient to correct and prevent recurrence of the nonconformity."
FDA also said in another observation that product "found with contamination during inspections at the final clean operation are not documented using a nonconformance report" while in another observation, the site’s software used as part of the quality system "has not been adequately validated for its intended use according to an established protocol."
Zimmer did not respond to a request for comment. A company plant in Montreal received a warning letter in 2016.