FDA WARNING_LETTER - Krier Foods, Inc. - November 14, 2012

The FDA conducted an inspection of Krier Foods, Inc. from October to November 2012, identifying serious violations of Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR Part 111). These violations render the dietary supplement products, including (b)(4) and (b)(4), adulterated. Although the firm stated they ceased manufacturing these specific products as dietary supplements, they remain responsible for compliance for previously manufactured and distributed products, including record retention and adverse event reporting.

Key violations include: 1. **Failure to establish component specifications (21 CFR 111.70(b))**: No identity, purity, strength, or composition specifications for components. 2. **Failure to establish finished product specifications (21 CFR 111.70(e))**: Missing identity and strength specifications for finished batches of products like (b)(4). 3. **Failure to prepare Master Manufacturing Records (MMRs) (21 CFR 111.205(a))**: MMRs were not available for each unique formulation and batch size, and lacked required details like declared dietary ingredient weights. 4. **Incomplete Batch Production Records (BPRs) (21 CFR 111.255(b), 111.260)**: BPRs lacked information on equipment maintenance, packaging identifiers, and initials for component