2. Your firm failed to establish written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
You failed to validate your drug manufacturing processes. Unvalidated production processes increase the probability that your products will vary in identity, strength, quality, and purity. Your failure to validate your drug manufacturing processes means that you cannot assure consistency in the quality of your finished products and may result in variable levels of potentially toxic ingredients in them.
Your homeopathic drug products are indicated for treating conditions in infants and children, and they are manufactured from ingredients such as Nux vomica, Belladonna, Aconitum napellus, and Gelsemium sempervirents that pose potentially toxic effects. For example, Nux vomica contains strychnine. Strychnine is a highly toxic, well-studied poison that is used as a rodenticide.
You released numerous lots of homeopathic drugs without validating your manufacturing processes. Before any batch is commercially distributed for use by consumers, a manufacturer should have gained a high degree of assurance in the performance of the manufacturing process such that it will consistently produce drug products meeting attributes relating to identity, strength, quality, and purity. Information and data should determine if the commercial manufacturing process is capable of consistently producing acceptable quality products under commercial manufacturing conditions. Failure to validate manufacturing processes could expose patients to unnecessary risks due to the lack of knowledge about and control over sources of variation.
This is a repeat and persistent observation that was also cited during inspections conducted in 2012 and 2017.