FDA WARNING_LETTER - B & B Pharmaceuticals, Inc. - October 30, 2018

The FDA inspected B&B Pharmaceuticals, Inc. (FEI 3000719772) in Englewood, Colorado, from October 17-30, 2018, identifying significant Current Good Manufacturing Practice (CGMP) deviations for Active Pharmaceutical Ingredients (API). This renders their API adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Quality Unit (QU) Failures:** The QU failed to thoroughly investigate complaints (e.g., subpotent progesterone and meperidine, particle size issues) and did not determine root causes or routinely notify original API manufacturers. The QU also failed to adequately review batch records for completeness and accuracy, missing discrepancies and lacking signatures. Additionally, QU personnel were not independent of production operations. 2. **Cleaning Validation:** The firm failed to conduct adequate cleaning validation studies for non-dedicated equipment to prevent cross-contamination, especially for highly potent drugs. A 2008 study from a different location was deemed insufficient. 3. **Certificates of Analysis (COA):** B&B Pharmaceuticals omitted the name and address of original API manufacturers on COAs issued to customers and did not include copies of original batch certificates, compromising supply chain accountability.

The FDA found the company's November 2, 2018, response inadequate, particularly regarding the limited scope of