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# 5 Observations in Alembic FDA Inspection
- URL: https://www.fdaweb.com/5-observations-in-alembic-fda-inspection/
- Published: 2023-01-12T12:00:00.000Z
- Updated: 2026-09-14T18:11:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153523

An FDA inspection at the Alembic Pharmaceuticals solid oral drug formulation manufacturing facility in Jarod, Gujarat, India, resulted in an FDA-483 with five observations. The Indian financial news platform *BQ Prime* [reports](https://www.bqprime.com/business/us-fda-flags-five-procedural-lapses-at-alembic-pharmaceuticals-jarod-facility?ref=fdaweb.com) the company disclosed the 12/8-12/16/22 inspection in a financial exchange filing. *BQ Prime* says it obtained these five inspection observations from FDA:

- equipment and utensils are not cleaned or sanitized at appropriate intervals to prevent contamination that could affect the safety and quality of the drug;
- failing to establish procedures designed to prevent objectionable microorganisms in drug products not required to be sterile;
- failing to establish adequate written procedures for production and process controls designed to assure the quality and purity of drug products.
- aseptic processing areas are deficient in systems for monitoring environmental conditions; and
- failing to fully follow the responsibilities and procedures applicable to the quality control unit.

In its filing, Alembic said none of the observations related to data integrity and said the company would respond to FDA within the required time.