Sharp Global Limited – FDA Warning Letter, Mar 10, 2014

This FDA Warning Letter, dated October 15, 2014, was issued to Sharp Global Limited following a March 2014 inspection of their New Delhi, India, pharmaceutical manufacturing facility. The inspection revealed significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs), rendering their APIs adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to prevent unauthorized data access/changes:** The firm's NuCon 5700 gas chromatographs (GCs) lacked access controls and audit trail functions, allowing deletion or alteration of raw data. Laboratory practice involved deleting raw data after printing chromatograms, leading to incomplete data retention. 2. **Failure to control batch records:** Uncontrolled batch records were found, with operators able to print them from personal computers and blank records present in the production office. 3. **Failure in documentation and record controls:** Correction tape and fluid were used in logbooks, obscuring original entries. An authorizing production official failed to sign an in-process batch record. 4. **Failure to validate non-compendial analytical test methods:** The firm failed to validate the non-compendial method for chromatographic purity of (b)(4) USP, and system suitability was inadequate.

Additionally, the firm failed to fulfill drug establishment registration and listing obligations under Section 510