Wednesday, February 28, 2018

Warning Letter of the Week: busted gaskets edition

A friendly missive to the CEO of Alchymars ICM SM Private Limited in Chennai, India from the good folks at the Center for Drug Evaluation and Research:  
2. Failure to properly maintain equipment and to keep complete records of major equipment maintenance.
Our investigator found damaged product-contact surfaces on your multi-product equipment. For example, the manhole gasket of [redacted]111 was deteriorating and wrapped in peeling tape. A gasket on the [redacted]102 was also cracked in one area and wrapped in peeling tape.

Your SOP/ENG/39-1, Gasket Management for Equipments and Pipelines which are in Direct Contact with the Product, section 4.18, requires you to replace gaskets in critical areas, including gaskets for [redacted]111 and [redacted]102, [redacted]. Your firm was unable to provide gasket replacement records for this equipment during the inspection.

Furthermore, the most recent records of your firm checking the condition of the gaskets for [redacted]102 were from January 2017, more than [redacted] before our inspection.

This is a repeat observation from our February 2015 inspection. We also note that you have found deteriorating gaskets to be the root cause for finished API particle complaints.

Your response is inadequate. You stated that the “involved gasket was immediately substituted” but did not evaluate all other gaskets on your manufacturing equipment. You indicated that you will update your procedure to require a supervisor walk-through to assess product contact surfaces, but did not include sufficient detail (e.g., frequency of equipment inspection). You also failed to address the lack of gasket maintenance records.
Gaskets are cheap, aren't they? Better a couple of bucks for gasket than particles in your API... 


  1. Gaskets are cheap. Tape is much cheaper. The company officers probably received training at the Charles Harper School of Business Ethics. (Two and a Half Men reference).

    1. Actually, I'd love to know the price of a manhole-sized gasket made from a material that can withstand a cleaning regimen and still be suitable for product contact. I know we're not talking about a 50-cent O-ring here, but what is this likely to be? Are we talking about a couple pounds of Viton or something?

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