Kabco Pharmaceuticals, Inc. – FDA Warning Letter, Jul 7, 2010

The FDA inspected Kabco Pharmaceuticals, Inc. from June 21-24, 2010, and July 7, 2010, finding numerous violations of 21 CFR Part 111, Current Good Manufacturing Practice (CGMP) for dietary supplements. The inspection revealed that several dietary supplement products, including (b)(4) Tablet, (b)(4) Capsule, (b)(4) Tablet, and (b)(4) Capsule, were adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key deficiencies included: 1. **Failure to determine component specifications before use (21 CFR 111.75(a))**: The firm did not conduct identity testing on dietary ingredients (e.g., L-carnitine, valerian root, ginkgo biloba) and failed to qualify suppliers of other components by confirming Certificate of Analysis results. The firm's response was inadequate due to lack of documentation and a plan for distributed products. 2. **Incomplete Master Manufacturing Records (MMR) (21 CFR 111.210)**: MMRs for products like (b)(4) Tablet and (b)(4) Capsule lacked weight/measure of ingredients and sampling procedures. The firm's response was inadequate as it did not provide revised MMRs, updated SOPs, or sufficient