Wednesday, April 11, 2018

Warning Letter of the Week: "we made it, it's good" edition

1.    Your firm failed to maintain adequate separate defined areas necessary to prevent contamination or mix-up (21 CFR 211.42(c)).
You manufacture several over-the-counter (OTC) drug products and medicated otic and oral care products under contract. These drugs include [redacted] Ear Wax Drops, [redacted] Oral Rinse, and fluoride toothpastes. You also manufacture numerous non-pharmaceutical materials in your facility, including a weed killer and adhesive remover. 
You did not utilize any quarantine markings or physical segregation of finished drug products from the lawn care and cleaning chemicals in your warehouse. You did not designate your quarantined finished drug products with quarantined status. During the inspection, your Vice President of Operations stated that your firm does not quarantine any finished products before they are released by quality because you “thought of the product as good once it was manufactured.”

Your response stated that your warehousing space is “tight,” and you have recently acquired additional off-site space to store packaging components. You also stated that you would implement a procedure by July 1, 2017, for labeling the status of finished drug products.
Just in case you were thinking about mixing the lawn care products and the toothpaste... 

3 comments:

  1. When people complain about "job-killing regulations" I'll show them this letter. When Judy Collins asks where are the clowns, you can tell her at Continental Manufacturing Chemist, Inc.

    The correct link is

    http://www.fda.gov/iceci/enforcementactions/warningletters/2017/ucm591326.htm

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    Replies
    1. "You have failed to correct repeat violations which have been observed in previous inspections and advisory actions from 2009–2014. Specifically, charges 1, 2, and 3 were repeat violations from a Regulatory Meeting held on May 13, 2010, as well as in an Untitled Letter dated November 27, 2013."

      Ridiculous.

      Delete
  2. Sounds like someone trying to play by 1890's rules in 2018 America. At least they aren't making fuel additives?

    I don't think I'd be buying meat from anyone related to or owned by their management.

    ReplyDelete