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# CGMP Problems at Singapore’s Opto-Pharm
- URL: https://www.fdaweb.com/cgmp-problems-at-singapores-opto-pharm/
- Published: 2017-03-28T12:00:00.000Z
- Updated: 2026-09-14T22:14:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138314

A 3/14-3/22/16 FDA inspection at Opto-Pharm, Singapore, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 3/16 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm547904.htm?ref=fdaweb.com). Specific violations observed during the inspection included

- failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
- failing to establish the reliability of the container-closure supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals; and
- failing to ensure that drug products bore an expiration data supported by appropriate stability testing.

The letter also notes that the firm’s OTC eyewashes don’t comply with the final monograph for ophthalmic drug products for over-the-counter use because the product names suggest that they are intended for flushing both the eye and skin, and flushing the skin is not an approved indication.

FDA recommended that the firm engage a consultant to assist it in meeting CGMP requirements. Opto-Pharm was told to respond with a list of actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.