During our inspection, our investigator observed specific violations including, but not limited to, the following.For those who need some context, Hyland's Teething Tablets are (or were) a fairly common product in American drug stores. They are believed (incorrectly, I assert) to relieve teething pains in children. (I recall turning up my nose at these products because they are labeled as homeopathic.)
1. Your firm failed to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product (21 CFR 211.110(a)).
Your firm released multiple lots of homeopathic in-process powder blends prior to attempting to validate your manufacturing process. You manufacture [redacted] homeopathic in-process powder blend mixtures which you send to Raritan Pharmaceuticals Inc. (Raritan), a contract manufacturing organization, to produce finished homeopathic drug products for the United States (U.S.) market. Some of your powder blend mixtures are manufactured from ingredients that pose potentially toxic effects. For example, your Infants’ Teething Tablet [redacted] contains belladonna. Raritan uses this powder blend mixture to produce finished drug products for infants and children, a population vulnerable to the toxic effects of belladonna. You shipped [redacted] lot [redacted] of Infants’ Teething Tablet [redacted] to the U.S. market before evaluating whether your manufacturing process was reliable and reproducible.
Your operators use a [redacted], an inherently variable process, to [redacted] produce in-process powder blends, including those made from toxic ingredients. You did not test the in-process powder blends for adequacy of mixing to assure uniformity and homogeneity prior to release and shipment to your contract manufacturer, Raritan.
FDA collected samples of your in-process drugs ([redacted] lot [redacted]) during our September-October 2016 inspection of Raritan. FDA analyses indicated that your in-process drugs were not homogeneous in composition.
Raritan used your powder blends to contract manufacture adulterated finished drug products that you marketed for use in infants and children in the United States. FDA analysis of finished drug products made from your in-process blends also demonstrated non-homogeneous composition. We acknowledge that the teething tablets made from your non-uniform powder blends were recalled.
As it turns out, they weren't very homeopathic, and the health news website STAT had a long article in February detailing the many hundreds of children who were injured (and the 10 children who died) by the belladonna (a poison!) that was used as the active ingredient in these tablets.
As a parent and a scientist (and someone who works around the pharmaceutical manufacturing space), I am saddened and angered that non-homogeneous blending was the final hole in the Swiss cheese that allowed these poisonous tablets to be released to the public.
(Don't miss the "limited photography" section in the warning letter: "Your consultant impeded the inspection by preventing our investigator from photographing this piece of equipment.")