Dextrum Laboratories Inc.

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 (21 CFR 211.84(d)(1)).

Passage 2

Your firm failed to conduct microbiological testing before use of each lot of a component with potential for objectionable microbiological contamination in light of its intended use. (21 CFR 211.84(d)(6)).

Passage 3

Your firm failed to establish adequate written procedures for production and process control 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)).

Passage 4

Your firm failed to adequately validate your production and process controls. As such, you do not have assurance that you are capable of consistently manufacturing OTC drug products with defined quality attributes. For example, your firm contract manufactures an OTC drug product, **(b)(4)**, but failed to adequately validate your production and process controls specifically for this product. Your production and process validation protocol, “Process Qualification (PQ) Protocol – Mixing / Formulation

Passage 5

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.