> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA 483 Cites Quality Deficiencies at Indian Drug Plant
- URL: https://www.fdaweb.com/fda-483-cites-quality-deficiencies-at-indian-drug-plant/
- Published: 2025-11-07T12:00:00.000Z
- Updated: 2026-09-14T15:26:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160180

FDA has cited Medispray Laboratories, a finished drug product manufacturer based in Ponda, Goa, India, for significant lapses in its quality control (QC) procedures following a January inspection at its facility. According to a just-posted Form FDA 483, investigators found that the company’s quality control responsibilities and procedures were not fully written or followed, raising concerns about data integrity and oversight of manufacturing operations.

The FDA’s [inspectional observations](https://www.fda.gov/media/189505/download?ref=fdaweb.com) noted that during a walkthrough, investigators noticed a QC test result for an in-process product was stopped by a user after a sensor disconnection, and the initial measurement was marked as “Cancelled” and “Failed.” A new test run was later completed and recorded as “Pass,” but no written quality assessment, incident report, or investigation was conducted to explain the failure or determine whether it impacted product quality.

In addition, inspectors found that the company’s standard operating procedures did not specify how to handle failed measurements or sensor disconnections — a critical omission in ensuring reliable analytical testing.

The report also cited shared computer access in the quality control area, noting that a standalone computer used for in-process testing was operated under a common login ID and password accessible to several employees across quality assurance and manufacturing. The lack of individual user credentials undermines traceability and accountability in laboratory data management, a recurrent concern in FDA inspections of overseas facilities.