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# ‘Insanitary Conditions’ at India’s Global Pharma
- URL: https://www.fdaweb.com/insanitary-conditions-at-indias-global-pharma/
- Published: 2023-11-14T12:00:00.000Z
- Updated: 2026-09-14T14:16:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155782

A 2/20-3/2 FDA inspection at Global Pharma Healthcare in Tamil Nadu, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 10/19 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-pharma-healthcare-private-limited-657325-10192023?ref=fdaweb.com) says the firm’s drug products are adulterated because they were “prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health.”

The letter says FDA and the Centers for Disease Control and Prevention investigated a multi-state outbreak of antibiotic-resistant *Pseudomonas aeruginosa* that ultimately affected over 80 patients and led to four patient deaths and at least 14 cases of vision loss. As part of the investigation, FDA collected samples of artificial tears and artificial eye ointment that were manufactured by Global Pharma. According to the letter, agency lab analysis found that 18 batches of artificial tears were non-sterile, as was a batch of artificial eye ointment.

“The testing of these intact units revealed that your ophthalmic drug products were intrinsically contaminated with microorganisms,” FDA says…. “Significantly, the pervasive contamination of your drug products, as indicated by FDA sample results, also demonstrates that all drugs made at your facility are adulterated … as they have been manufactured under insanitary conditions. In addition, two intact samples of artificial tears from different batches were found to contain visible, foreign particles.”

FDA cites these CGMP violations:

- failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
- failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failing to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
- failing to establish a system for monitoring environmental conditions in aseptic processing areas and an adequate system for cleaning and disinfecting the room to produce aseptic conditions;
- failing to establish the accuracy, sensitivity, specificity, and reproducibility of test methods, and failing to conduct appropriate laboratory testing to determine whether each batch of drug product purporting to be sterile conforms to such requirements; and
- failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter says the firm’s quality system does not adequately assure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. FDA recommends that it retain a qualified consultant to assist in remediation.

The letter also addresses misbranded drug violations, drug recalls the firm initiated, and Global Pharma’s suspension of drug production for the U.S. market. FDA says Global should retain a consultant to assist it in meeting CGMP requirements if it decides to resume drug production for the U.S. market.

The agency reminds Global that it is responsible for the quality of drugs it produces as a contractor, regardless of agreements in place with product owners.

“Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP,” FDA says. “In addition to a severe lack of production oversight of facilities and equipment, we found your quality unit is not enabled to exercise proper authority and has insufficiently implemented its responsibilities. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements.”

Global Pharma was placed on an Import Alert on 1/3 after the firm’s response to FDA’s 11/15/22 records request demonstrated CGMP violations related to controls for diethylene glycol and ethylene glycol in high-risk components used in its drugs.

Global was told to correct violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.