FDA issued a Warning Letter to Instratek, Incorporated on 8/23/2012 as a result of this inspection.
FDA investigators audited the Instratek - Houston, TX, United States facility and issued 9 inspectional observations (via FDA 483) on 24 Apr 2012.
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- Category: Medical Devices & Rad Health
- Number of Observations: 9
- Inspection end: 24 Apr 2012
- Location: Houston, United States
- FEI: 1000118334