Wednesday, April 3, 2019

Warning Letter of the Week: live moth edition

A missive from the Center for Drug Evaluation and Research to the owner of B. Jain Pharmaceuticals Pvt. Ltd.:
1.    Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin (21 CFR 211.56(a)). 
In the raw material storage room our investigator observed numerous flying insects. FDA observed your staff dispensing [redacted] raw material for use in production, batch #[redacted], in this room and a live moth was observed floating in this raw material. You use [redacted] to manufacture your homeopathic drug products. When the investigator pointed out the presence of this moth in your [redacted] raw material, you continued to manufacture homeopathic drug products using the raw material contaminated with the insect.

In addition, various raw materials, some packaged in burlap sacks, were observed scattered across your quarantine room, and the ceiling in this room was stained with what appeared to be mold. Leaking containers of one raw material were observed in close proximity to other raw materials in your warehouse and what appeared to be unidentified [redacted] were observed adhering to the air vents in the production areas which are used to manufacture multiple homeopathic drug products.
It's really hard to keep the vermin out of the product, it really is.

3 comments:

  1. Moth parts is an active ingredient of their product.

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  2. Moth in the raw material for a homeopathic prep? That could be quite a problem if they dilute it enough....

    ReplyDelete
  3. The moth was 100% organic.

    ReplyDelete