FDA 483 - Mixlab TX LLC - February 03, 2012
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On February 3, 2012, the FDA issued a Form 483 to Weatherford Compounding Pharmacy LLC, a veterinary compounding pharmacy located at 175 College Park Drive #175, Weatherford, TX 76086. The inspection, conducted on 10/3-5/11, 10/13/11, and 2/3/12, identified five observations.
Observation #1 noted a lack of documentation for media fills to validate the sterilization process for compounded sterile preparations (CSPs) for parenteral use, citing examples like Enrofloxacin/Flunixin/Vitamin B12 (lot #EFB0911), Ceftiofur/Enrofloxacin/Vitamin B12 (lot #CFE110110), and Tulathromycin/Ceftiofur/Flunixin (lot #TCF111810).
Observation #2 indicated a failure to provide data demonstrating depyrogenation of glass vials and closures used in CSP compounding.
Observation #3 stated that documentation was not provided to show that the firm conducted (b)(4) after CSP compounding.
Observation #4 highlighted a failure to investigate potency failures for CSPs, specifically Ceftiofur/Flunixin/Vitamin B-12 (lot #CEF091010) with potency results of 73.
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