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Zimmer Biomet (ZBH) published its response to the Form 483 issued by FDA in April 2018, related to inspectional observations at the Warsaw North Campus manufacturing facility. The company reiterated that none of the observations identified specific performance issues with particular products, and that all products continue to be manufactured in the facility.
The Form 483 issued in April included three new and eight repeating observations from the inspection conducted from September to November 2016 (which yielded 14 observations). The April Form 483 included observations addressing corrective actions to prevent recurrence of bacterial failures in polyethylene devices, sterilization cycle validation, risk analysis for sterile packaging, lack of documentation on test methods, procedures to control environmental conditions, inadequate training procedures, etc.
In its newly-published 98-page response, ZBH stated disagreement with certain aspects of some of the observations, based on perceived misunderstanding on behalf of the investigators, a lack of context, incomplete information reported by ZBH representatives, etc. Specifically, the company gave responses to the following observations:
| Observation Number | Observation |
| 1(A) | ZBH did not implement corrective actions sufficient to prevent recurrence of bacterial endotoxin text excursions |
| 1(B) | ZBH has not taken action commensurate with risk with respect to cleaning validations |
| 2 | Relates to validation of a sterilization process (previously used, now replaced) |
| 10 | ZBH did not adequately establish process controls for a specific packaging sealer (since removed in accordance with an obsolescence plan) |
In the company’s 1Q18 call, CEO Bryan Hanson noted that recovery in knee, hip and S.E.T. is on track with a goal to restore supply in substantially all key brands by the beginning of 3Q18.
Sources: Zimmer Biomet, Inc.; The Journal Gazette; ORTHOWORLD Inc.
Zimmer Biomet (ZBH) published its response to the Form 483 issued by FDA in April 2018, related to inspectional observations at the Warsaw North Campus manufacturing facility. The company reiterated that none of the observations identified specific performance issues with particular products, and that all products continue to be manufactured in...
Zimmer Biomet (ZBH) published its response to the Form 483 issued by FDA in April 2018, related to inspectional observations at the Warsaw North Campus manufacturing facility. The company reiterated that none of the observations identified specific performance issues with particular products, and that all products continue to be manufactured in the facility.
The Form 483 issued in April included three new and eight repeating observations from the inspection conducted from September to November 2016 (which yielded 14 observations). The April Form 483 included observations addressing corrective actions to prevent recurrence of bacterial failures in polyethylene devices, sterilization cycle validation, risk analysis for sterile packaging, lack of documentation on test methods, procedures to control environmental conditions, inadequate training procedures, etc.
In its newly-published 98-page response, ZBH stated disagreement with certain aspects of some of the observations, based on perceived misunderstanding on behalf of the investigators, a lack of context, incomplete information reported by ZBH representatives, etc. Specifically, the company gave responses to the following observations:
| Observation Number | Observation |
| 1(A) | ZBH did not implement corrective actions sufficient to prevent recurrence of bacterial endotoxin text excursions |
| 1(B) | ZBH has not taken action commensurate with risk with respect to cleaning validations |
| 2 | Relates to validation of a sterilization process (previously used, now replaced) |
| 10 | ZBH did not adequately establish process controls for a specific packaging sealer (since removed in accordance with an obsolescence plan) |
In the company’s 1Q18 call, CEO Bryan Hanson noted that recovery in knee, hip and S.E.T. is on track with a goal to restore supply in substantially all key brands by the beginning of 3Q18.
Sources: Zimmer Biomet, Inc.; The Journal Gazette; ORTHOWORLD Inc.
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
