FDA WARNING_LETTER - Hospira Healthcare India Pvt. Ltd. - April 03, 2018

The FDA issued a Warning Letter to Hospira Healthcare India Pvt. Ltd. following an inspection from March 27 to April 3, 2018, citing significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Incomplete Laboratory Records (21 CFR 211.194(a)):** The microbiology laboratory inaccurately reported test results, with analysts recording "Nil" for plates showing microbial growth. This compromised sterility assurance and raised concerns about the validity of all quality control laboratory results. 2. **Inadequate Investigation of Discrepancies (21 CFR 211.192):** The firm failed to thoroughly investigate recurring critical defects and poor control in their manufacturing process, specifically regarding excessive critical defect rates in batches and issues with the manufacturing process leading to quality attribute specification failures. 3. **Failure to Conform to Final Specifications (21 CFR 211.165(a)):** Drug product batches were released without appropriate laboratory determination of satisfactory conformance to final specifications. Retesting of previously "passing" batches under FDA observation yielded Out-of-Specification (OOS) results, indicating data integrity issues related to testing procedures.

The FDA noted the firm's decision to suspend drug product release and recall affected batches. The Warning Letter emphasizes the need for a comprehensive investigation into the extent of data