Health Plus 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 ensure that returned drugs meet appropriate standards of safety, identity, strength, quality and purity prior to redistributing (21 CFR 211.204).

Passage 2

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 3

Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).

Passage 4

Your firm failed to follow a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

Passage 5

You failed to establish, review, and approve all procedures, including those which may impact the safety, identity, strength, quality, and purity of your drug product. Specifically, your QU failed to implement SOPs that are critical to ensure the quality of the drug product, such as the SOPs for operating the equipment used to manufacture the drug product.

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.