Atlantic Management Resources LTD dba. Claire Ellen Products

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 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 2

Your firm failed to establish a quality unit (QU) with the responsibilities and authority to oversee the manufacture of your homeopathic drug products.

Passage 3

Your firm failed to store drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity are not affected (21 CFR 211.142(b)).

Passage 4

Your firm failed to prepare batch production and control records that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188(b)).

Passage 5

Your firm failed to have batch and control records that document your manufacturing operations. You stated that there were no batch records and no batch numbers. Batch records are required to capture significant information to assure that your drug products have been manufactured, processed, packed, or held properly.

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 CGMPs. We may re-inspect to verify that you have completed corrective actions to address any violations.