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# Panacea Biotec Inspection is OAI
- URL: https://www.fdaweb.com/panacea-biotec-inspection-is-oai/
- Published: 2022-09-08T12:00:00.000Z
- Updated: 2026-09-14T17:58:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152697

In a filing with the National Stock Exchange of India, Panacea Biotec says it has been informed by FDA that the classification of the agency’s 5/30-6/8 inspection at the Panacea facility in Baddi, Himachal Pradesh, India, is “Official Action Indicated.” The [filing](https://media.panaceabiotec.com/corporate-announcement/updateonusfdainspectionatmanufacturingfacilityofpbpl-08092022.pdf?ref=fdaweb.com) says the classification means that FDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from that facility until the outstanding observations are resolved.

The [inspection](https://media.panaceabiotec.com/corporate-announcement/2022/USFDA-inspection-at-pharmaceutical-formulation-facility.pdf?ref=fdaweb.com) had eight observations on Form FDA-483\. Additionally, Panacea Biotec notes that work is still underway to close a 9/24/2020 [Warning Letter](https://www.fdaweb.com/cgmp-violations-at-panacea-biotec/), which recommended that it engage a qualified consultant to assist it in meeting GMP requirements cited in a 2/2020 inspection. Specific violations cited in the letter 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.