Hospira Healthcare India Pvt. Ltd. – FDA 483, Apr 3, 2018

This FDA Form 483 details significant quality system and manufacturing deficiencies. The Quality Unit failed to ensure cGMP adoption, adequate analytical method validation/transfer, accurate test results, and appropriate investigation of events. This is a recurrent observation from a 2016 inspection.

Microbiology laboratory data is unreliable, with discrepancies between recorded and actual microbial growth counts for personnel monitoring. For example, several samples reported as "Nil" growth actually showed counts of 1 to 6, or "Growth observed. Unable to determine total number of cfu."

QC Chemistry Analysts manipulated test sample weights to obtain passing results for [Redacted] tests for multiple batches of [Redacted] Injection USP raw materials and finished product. Six batches retested during the inspection failed to meet specifications. Historical data showed unusual consistency in sample weights and percentages.

Investigations into unexplained discrepancies and out-of-specification (OOS) results are not thorough or timely. An investigation (PR #231167) into OOS unknown impurities in Injection USP batches, initiated in November 2017, found the existing HPLC method was not stability indicating. An unapproved UPLC method was used, and recalculations with a critical impurity correction factor led to OOS results for twelve distributed batches. As of March 2018, no market action was taken, and seven batches had expired.

Customer complaints, such as particulates in Injection finished product (PR #17938