I am writing today to announce the closure of the Michigan Messenger. After four years of operation in Michigan, the board of the American Independent News Network, has decided to shift publication of its news into a single site, The American Independent at Americanindependent.com. This is part of a shift in strategy, towards new forms [...]
An abstinence-only presentation provided to numerous school districts in Calhoun and Eaton Counties in October of this year provided false and misleading information to students about HIV, experts allege.
Two county registers of deeds filed a class action lawsuit Monday on behalf of Michigan’s 83 counties alleging that the Mortgage Electronic Registration Services owes millions of dollars in property title transfer taxes.
Despite evidence of the impact of mercury on children and public health, Michigan Attorney General Bill Schuette last month joined with 24 other state attorneys general in filing a lawsuit to scuttle new EPA regulations that would reduce mercury emissions from power plants.
The U.S. Food and Drug Administration has issued a violation to Michigan-based Perrigo, the largest maker of generic over-the-counter drugs in the United States, for shipping out boxes of ibuprofen with metal shavings in the pills as a result of a machine malfunction. The letter, posted to the FDA website, alleges that the company did not do adequate follow up to make sure they had contained the contamination. It says, in part:
1. Your firm failed to reject drug products failing to meet established standards or specifications and any other relevant quality control criteria [21 C.F.R. § 211.165(f)].
For example, your firm failed to reject a lot of lbuprofen Tablets 200 mg (lot 9BE1961) that was contaminated with metal shavings due to an equipment failure. Although your firm segregated a portion of the lot that was affected, you released and shipped a subportion of that segregated lot, resulting in a recall of the entire lot.
2. Your firm failed to thoroughly investigate the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed and extend investigations to other batches of the same drug product and other drug products that may have been associated with the specific failure [21 C.F.R. § 211.192].
For example, your firm did not thoroughly investigate possible foreign tablet contamination in your filling equipment. After finding a brown, round Ibuprofen tablet (lot 8ME1624) in a lot of brown, oval Ibuprofen caplets (lot 8ME1731), you did not inspect the lot of orange, round Ibuprofen tablets (lot 8ME1728) that was packaged between lot 8MEl624 and lot 8ME1731. Without extending your investigation to lot 8MEI728, there is no assurance that this lot was not also contaminated.
Your response is inadequate it that it neither provides scientific rationale for excluding lot 8ME1728 from your investigation, nor does it address examination of any remaining product.
Perrigo must take steps to correct the problems within 15 working days and inform the FDA of the efficacy of those steps.
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