FDA WARNING_LETTER - Bryant Ranch Prepack Inc. - June 11, 2009

An FDA inspection conducted from June 2-11, 2009, at Bryant Ranch Prepack's North Hollywood, CA facility revealed significant Current Good Manufacturing Practice (CGMP) deviations, rendering its drug products adulterated under 21 U.S.C. § 351(a)(2)(B). Key violations included the lack of separated air-handling systems for (b)(4) products (21 CFR § 211.46(d)), despite the firm's August 2009 response claiming corrective actions. The firm also failed to establish separate or defined areas to prevent contamination and mix-ups (21 CFR § 211.42(c)(5)), with (b)(4) operations not performed in separate facilities (21 CFR § 211.42(d)). Additionally, the firm did not test (b)(4) drug products for cross-contamination with (b)(4) (21 CFR § 211.176) and lacked a written stability testing program for drug products, particularly repackaged liquids (21 CFR § 211.166(a)). Beyond CGMP issues, Bryant Ranch Prepack was found to be manufacturing and distributing unapproved new drugs, such as (b)(4) and (b)(4), without FDA-approved applications, violating sections 301(a), (d) and 505(a) of the Act. These products were also deemed misbranded under section 502(f)(1) of the Act due to inadequate directions for use. The FDA requires prompt corrective action within fifteen working days, including a written response detailing steps taken, recurrence prevention, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction, and could impact federal contracts or future drug approvals.