Sovereign Pharmaceuticals, LLC

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 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, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).

Passage 2

Your firm failed to adequately validate the manufacturing processes for bulk **(b)(4)** tablets. Specifically, during process performance qualification (PPQ) for in-process blend powder drum assay testing, several out-of-specification (OOS) results were obtained for at least one of your active ingredients, **(b)(4)** and/or **(b)(4)**.

Passage 3

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 4

Your firm failed to adequately perform a timely and thorough investigation into the in-process OOS results obtained for your **(b)(4)** tablet drug products. For example, FDA investigators found that approximately 27 validation and commercial batches of **(b)(4)** tablets with different strengths failed your blend powder drum assay acceptance criteria and were compressed and released before being adequately investigated.

Passage 5

Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)).

Passage 6

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.