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Weekly UpdatesHawkins, Inc., Minneapolis, MN Minneapolis District
FDA investigator Melissa Michurski observed multiple quality system failures in her inspection of API repackager Hawkins, Inc.
Of 155 APIs repackaged by the company, the inspector observed that 123 lacked expiration/retest dating, the 10-item 483 stated. Hawkins also lacked stability data to support retest dates or the lack of such dates. Further, in addition to labeling 32 of the 155 APIs with a re-assay date, "the firm is putting a re-assay date on all Certificates of Analysis for repackaged APIs," the FDAer stated.
Hawkins had no written procedures describing responsibilities of and procedures applicable to its quality control unit, Michurski wrote in the 483 after the inspection that took place March 28-31 and April 5, 7 and 10, 2006.
The firm did not take or maintain a retain sample of its repackaged APIs.
Despite internal procedures requiring certain audits every two years, Hawkins had not conducted some audits since 2002 and never conducted other audits at all, the FDA inspector noted.
No documentation showed that the firm changed pre- and post-filters on air handling units in repackaging suites as required. "The firm's SOP states filters are to be changed monthly on the first Friday after the 1st," Michurski reported.
Hawkins did not follow its procedures for closing product integrity complaints within one to three months, the FDAer found. Six out of the 10 complaints she reviewed were closed later than procedure required. Some complaints remained open for up to nine months.
Five out of ten complaints reviewed lacked a complete investigation, Michurski added. In three of the five cases, Hawkins had no retain sample of the API in dispute.
The firm had not validated the authenticity of its suppliers' Certificates of Analysis (COA) on a periodic basis--annually at minimum--when the COA was used in lieu of raw material testing, as its procedures required.
There were no written annual product reviews for any of the 155 APIs repackaged, the inspector reported.
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