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Article: Old Hickory slapped with 19-item 483 for multiple violations, warning letter for labeling flaws.(Human Drugs)
- Article from:
- Inspection Monitor
- Article date:
- January 1, 2005
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Old Hickory Medicine Company, Andalusia, AL, New Orleans District
Human and animal drug manufacturer Old Hickory Medicine Company in Andalusia, AL, received a 19-item 483 for numerous testing and specification flaws, as well as an April 21, 2004, warning letter for labeling violations. Marvin Jones from the New Orleans District Office conducted the investigation.
The warning letter stated that Old Hickory improperly labeled its drug products because the firm failed to differentiate between active and inactive ingredients.
For example, with Old Hickory Ear Drops, the warning letter noted that "the product's label bears claims, such as, 'For ...