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# FDA Hits India Drug Maker with 14-page 483
- URL: https://www.fdaweb.com/fda-hits-india-drug-maker-with-14-page-483/
- Published: 2023-03-31T12:00:00.000Z
- Updated: 2026-09-14T18:23:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154109

A recent inspection of Global Pharma Healthcare in Tamilnadu, India has led to a just-posted 14-page FDA [Form-483](https://www.fda.gov/media/166739/download?ref=fdaweb.com) that cites significant GMP deficiencies. For example, the form says the company’s procedures for preventing microbiological contamination were inadequate because they did not include validation of the sterilization process. Presumably, the inspection came about in reaction to several recalls involvng contaminated artificial tear drop products and a subsequent import alert involving the company ([see story](https://www.fdaweb.com/fda-warning-import-alert-on-contaminated-eyedrops/)).

The 2/20-3/2 inspection also cited the firm over its test methods. For example, it said the sterility method suitability testing for two ointment products did not meet “protocol acceptance criteria.” It also said the equipment used was not appropriate for its intended use.

Additionally, FDA said aseptic processing areas are deficient because the system for cleaning/disinfecting the room was not adequate. And the agency said the company failed to verify the identity of each component of a drug product, and it failed to validate the reliability of its component supplier’s test analyses at appropriate intervals.