FDA WARNING_LETTER - Yag Mag Labs Private Limited - July 02, 2011

This FDA Warning Letter, dated September 12, 2011, addresses Yag-Mag Labs Private Limited following a June 27 to July 2, 2011 inspection of their API manufacturing facility in India. The inspection revealed significant Current Good Manufacturing Practice (CGMP) deviations, rendering their APIs adulterated under 21 U.S.C. § 351(a)(2)(B).

Key violations include: 1. **Failure to document manufacturing operations concurrently:** Batch records for approximately (b)(4) batches of (b)(4) USP were admittedly written months after manufacturing and release, indicating a systemic data integrity failure. 2. **Inadequate facility design and construction:** Issues observed included residues/corrosion on equipment, materials exposed to outside elements, poorly identified/leaking piping, a recessed floor susceptible to flooding, and unsanitary restrooms. 3. **Lack of cross-contamination prevention:** No cleaning logs were used prior to April 2011, and personnel reported no cleaning between batches or product changeovers for non-dedicated equipment. 4. **Failure to prepare, review, and approve manufacturing documents:** The firm lacked written procedures for change control, OOS results, lab deviations, production discrepancy investigations, complaint handling, and annual product reviews. Batch record for batch (b)(4) was also inadequate, missing critical manufacturing instructions and test results. 5. **Inadequate control