Seaway Pharma 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 establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)).

Passage 2

You failed to ensure adequate quality unit (QU) oversight for release of your OTC drug products. For example, your QU failed to follow your procedure Batch Record Review and Release for Distribution, SOP No. QA-009, Revision 01, and between April 2024 and May 2025, released numerous batches of drug products for distribution prior to reviewing all test results to ensure they met specifications.

Passage 3

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 4

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 5

You failed to ensure adequate process validation for the OTC drug products you manufacture, including those indicated for infants and children. For example, you have not performed adequate process validation for the manufacture of your **(b)(4)** drug product to ensure control over batch-to-batch variability. For example:

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.