FDA issued a Warning Letter to Luitpold Pharmaceuticals, Inc. on 8/31/2011 as a result of this inspection.
FDA investigators audited the American Regent - Shirley, NY, United States facility and issued inspectional observations (via FDA 483) on 15 Mar 2011.
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- Category: Human Drugs
- Inspection end: 15 Mar 2011
- Location: Shirley, United States
- FEI: 2410375