FDA WARNING_LETTER - Hawkeye Jensen Inc - August 10, 2010

The FDA issued a Warning Letter to Hawkeye-Jensen, Inc. following inspections from June 14 to July 14, 2010, and August 4 to August 10, 2010, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211). These violations render their drug products adulterated under 21 U.S.C. § 351(a)(2)(B).

Specific CGMP violations include: 1. **Lack of validated cleaning procedures for equipment:** The firm failed to validate the cleaning process for a non-dedicated filler used for various products, lacking assurance against residual product and cleaner contamination. The firm's response was inadequate, lacking a timeframe for validation and an interim plan. 2. **Unvalidated water system:** The firm had not validated its water system used in drug manufacturing, failing to ensure consistent production of acceptable quality water. The provided data was insufficient, and deficiencies in microbiological testing (e.g., expired media, unvalidated methods, lack of growth promotion testing) were noted. This is a repeat observation from a September 2000 inspection. 3. **Failure of Quality Control Unit (QCU) to follow procedures:** The QCU did not adhere to SOPs for various responsibilities, including complaint documentation. The firm's response, citing added personnel, was