Miers Laboratories, Ltd

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 2

You failed to perform identity testing on a batch of **(b)(4)** containing up to **(b)(4)**% **(b)(4)**. You used this material as a solvent for **(b)(4)** tablets with homeopathic active pharmaceutical ingredients to manufacture numerous drug product batches for the U.S. market. The United States Pharmacopeia identity test for **(b)(4)** includes a **(b)(4)** limit of **(b)(4)** ppm. Your use of **(b)(4)** with **(b)(4)** is unacceptable.

Passage 3

You failed to perform adequate testing on homeopathic active pharmaceutical ingredients. For example, you used a batch of **(b)(4)** that was more than 14 years past its expiration to manufacture numerous batches of finished drug products without determining whether the component continued to meet quality attributes.