Sircle Laboratories, 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 responsibilities and procedures for reviewing batches made by your CMO. You also failed to review production records for each batch for disposition (i.e., reject or approve) per your QA with **(b)(4)**. You are ultimately responsible for approving or rejecting drug product batches manufactured for you by a contract facility. Determining the suitability of each batch for release is an essential component of your quality unit responsibility.

Passage 2

Your firm failed to follow establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product (21 CFR 211.198(a)).

Passage 3

Your firm failed to establish and follow written procedures designed to assure that correct labels, labeling, and packaging are used for drug products. (21 CFR 211.130)

Passage 4

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.