Bi-Coastal Pharma International

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 and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product, including provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation in accordance with 21 CFR 211.192. (21 CFR 211.198(a)).

Passage 2

Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d)).

Passage 3

You failed to establish adequate written responsibilities and procedures for reviewing manufacturing operations performed by your CMOs. You also failed to follow your established procedures, and review each batch produced for you to determine appropriate disposition. For example:

Passage 4

Your firm failed to ensure that each person responsible for supervising the manufacture, processing, packing, or holding of a drug product has the education, training or experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess (21 CFR 211.25(b)).

Passage 5

You failed to ensure personnel with oversight of quality related functions have the appropriate combination of training, education, and experience to perform the job adequately. For example, your QA manager:

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.