FDA WARNING_LETTER - Jalco Cosmetics Pty Ltd. - December 13, 2017

The FDA issued a Warning Letter to Jalco Cosmetics Pty. Ltd. following a December 11-13, 2017 inspection of their Hornsby, New South Wales, Australia drug manufacturing facility. The inspection revealed significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to test finished drug products:** Jalco released "(b)(4) Cream" without testing the identity and strength of active ingredients. The firm's response lacked a clear commitment to test all finished product attributes prior to release. 2. **Failure to test components:** The company did not test incoming active pharmaceutical ingredients and other components, relying solely on supplier Certificates of Analysis (COA) for identity. Their response was inadequate as it did not commit to establishing the reliability of supplier COAs. 3. **Lack of process validation:** Jalco failed to validate the manufacturing process for "(b)(4) Cream" and did not conduct equipment qualification for the R1 (b)(4) filling machine. Their response lacked a detailed process performance qualification protocol and an overall program for maintaining a validated process. 4. **Inadequate stability testing program:** The "(b)(4)-month" expiration date for "(b)(4) Cream" was based on a previous contract manufacturer's data, despite changes in manufacturing site, equipment, raw materials, and container-closures. The previous stability study