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# CGMP Violations at Panacea Biotec
- URL: https://www.fdaweb.com/cgmp-violations-at-panacea-biotec/
- Published: 2020-09-29T12:00:00.000Z
- Updated: 2026-09-14T16:30:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147751

A 2/10-2/20 FDA inspection at Panacea Biotec, New Delhi, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/24 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/panacea-biotec-limited-607837-09242020?ref=fdaweb.com) says specific violations were: 

- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
- failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

The letter says the agency strongly recommends that Panacea engage a qualified consultant to assist it in meeting CGMP requirements.

The company was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the actions.