FDA 483 - Front Range Laboratories, Incorporated - August 30, 2013

The FDA Form 483 details significant deficiencies observed during an inspection, primarily concerning laboratory controls, quality systems, personnel qualifications, and stability programs.

**Observation 1: Laboratory Controls** The facility lacks scientifically sound specifications, standards, sampling plans, and test procedures. Specifically, there is no verification of USP methods or validation of internal methods for drug testing. This includes: * **Sterility Testing:** Accelerated and 14-day sterility testing methods (MICRO-SOP-024, MICRO-SOP-009) lack validation, including equivalency studies to USP <71>, Growth Promotion Testing, and Bacteriostasis and Fungistasis tests. Subculturing of "fail" results to report "no growth" to customers without validation or proper investigation of failures is noted in 33 instances. Incubation times are inadequate for fastidious microorganisms, and subculture plates are not shown to support a wide range of growth. Gram staining is not performed on turbid broths. Definitive read dates for sterility tests are not recorded, and some 14-day tests were completed in less than 14 days. Anaerobic microorganisms may not be recovered due to aerobic incubation of subculture plates. * **Endotoxin Testing:** No method verification or preparatory studies have been performed for endotoxin testing. From May to August 2013, 83 endotoxin results showed negative positive controls, with 50