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A show cause notice has been issued to Mancare Laboratories for gross non-compliance during the manufacturing of Ofloxacin 200 mg Tablets, Batch No. MT250769. Key issues included continued production despite QA holds and unresolved quality problems, leading to a violation of GMP and company procedures. The recipients are required to provide a written explanation, including justifications, root causes, and corrective actions within 24 hours.

Author

S Singh Kushwaha

Language

EN