Material and supplier control Findings

There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Failure to have adequate written procedures for the sampling of raw materials.

Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). Your firm manufactures over-the-counter (OTC) (b)(4) drug products such as (b)(4) and ethanol- (b)(4) . You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., glycerin, propylene glycol, ethanol) used in the manufacture of your OTC (b)(4) drug products. Moreover, you used nonpharmaceutical-grade…

For component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary supplement are met, and limits on contamination to ensure the quality of the dietary supplement.

You did not conduct appropriate tests or examinations or rely on a certificate of analysis to determine whether components met established specifications.

Specific identification tests are not conducted on components that have been accepted based on the suppliers report of analysis.