FDA issued a Warning Letter to Hi-Tech Pharmacal Co., Inc. on 06/28/2010 as a result of this inspection.
FDA investigators audited the Hi-Tech Pharmacal, An AKORN Company - Amityville, NY, United States facility and issued 9 inspectional observations (via FDA 483) on 03 Dec 2009.
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- Category: Human Drugs
- Number of Observations: 9
- Inspection end: 03 Dec 2009
- Location: Amityville, United States
- FEI: 2433247