Copyright © 2018 Zydus Cadila. Ltd. - 557890 - 03/04/2019. Terms & Conditions. these violations are corrected, we may withhold approval of pending drug applications listing your facility. Links to sites outside of Pfizer Medical Information are provided as a resource to the viewer. The sapphire helps you deliver exceptional care. During our inspection, our investigators observed specific violations including, but not limited to, the following. The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Healthcare India Pvt. However, you did not include an assessment to determine whether other QC laboratory tests performed in the same laboratory were compromised by data integrity issues. On March 27, 2018, during a walk-through of your laboratory, our investigator observed microbial growth on (b)(4) personnel/environmental monitoring media plates associated with (b)(4) aseptic processing lines. Further, your investigation showed at least 8 different lots of different products had significant label deterioration. A status report for any of the above activities already underway or completed. Zydus Cadila, a leading Indian Pharmaceutical company is a fully integrated, global healthcare provider. … Your firm failed to adequately investigate poor control and critical defects in your (b)(4) manufacturing process. The products discussed herein may have different product labeling in different countries. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. 351(a)(2)(B). xample, on December 31, 2015, you received a complaint of particulate matter in a vial of vancomycin hydrochloride for injection, lot 565003A. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Ensuring the health, safety and well-being of our employees, patients, and the communities we serve across North America is always our top priority and especially critical at this time. In a Field Alert Report (FAR) of July 20, 2018, regarding OOS (b)(4) results, you indicated that “analysts performing the (b)(4) test did not perform the analysis in accordance with procedures and did not record the data accurately in the past.” Also, “there may be instances where testing results for the Karl Fisher test, gas chromatography, infrared spectroscopy and ultraviolet spectroscopy were not recorded accurately.”, Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. The German Breast Group (GBG) and Pfizer Inc. (NYSE: PFE) today announced that the collaborative Phase 3 PENELOPE-B trial did not meet the primary endpoint of improved invasive disease-free survival (iDFS) in women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early breast cancer (eBC) who have residual invasive disease after completing neoadjuvant … Your failure to report accurate data compromised the sterility assurance of drug products released from the facility and may have increased risks to patients.
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