Contract Pharmaceutical Services of Australia Pty Ltd – FDA Warning Letter, Nov 1, 2012

On May 17, 2013, the FDA issued a Warning Letter to Contract Pharmaceutical Services of Australia Pty. Ltd. following an inspection from October 30 to November 1, 2012. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations (21 CFR Parts 210 and 211) for finished pharmaceuticals, rendering their drug products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The firm also failed to fulfill drug establishment registration and listing obligations under Section 510(i)(1), 510(i)(2), and 510(j) of the Act, a prohibited act under Section 301(p).

Key violations include: 1. **Inadequate Environmental Controls (21 CFR 211.46(b)):** Blister rooms lacked mechanisms to maintain and control relative humidity (RH) for humidity-sensitive capsules, leading to potential brittleness and dose performance problems. The firm's response was inadequate as it did not address distributed product impact or future use of uncontrolled lines. 2. **Failure to Establish Time Limits (21 CFR 211.111):** Master packaging batch records (MPBR) lacked time limits for the packaging process of humidity-sensitive capsules, and there were no written procedures for