FDA Warns Singapore Drugmaker Over Validation, Labeling Issues

April 5, 2017

The FDA hit drugmaker Opto-Pharm with a warning letter, citing a lack of written procedures for preventing contamination of sterile drug products, as well as problems with validation, testing and labeling.

In a March 2016 inspection of Opto-Pharm’s Singapore facility, the FDA found numerous leaking product containers, which the facility routinely adjusted and then released the lots in question. Once the products reached the market, numerous consumers complained of leaking containers.

The inspectors also found evidence the firm re-used components intended for single use multiple times before discarding them.

Inspectors also found the firm did not establish the reliability of the ingredients used to seal its containers. The firm committed to sending samples of the ingredients for density testing and to periodically evaluate the supplier, but it could not provide justification for its acceptance criteria or external laboratory results.

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