Eco Lips, 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 an adequate 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 2

Your firm failed to establish an adequate stability program and determine appropriate expiration dates for the over-the-counter (OTC) drug products that you manufacture. Specifically:

Passage 3

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 4

Your firm failed to investigate out-of-specification (OOS) assay results for several batches of your OTC drug products. For example, **(b)(4)** product batches **(b)(4)** and **(b)(4)** were initially found to be OOS for assay.

Passage 5

Your firm failed to establish 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 6

Your firm failed to provide data to demonstrate that you have validated manufacturing processes for all your OTC sunscreen drug products. At the time of our inspection, process validation had not been completed for seven of the nine sunscreen product groups that your firm categorized based on active ingredient combinations and inactive ingredient composition.

Passage 7

Your firm failed to follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

Passage 8

Your firm failed to maintain written records so that the quality standards of each drug product can be evaluated at least annually to determine the need for changes in drug product specifications, manufacturing, or control procedures (21 CFR 211.180(e)).

Passage 9

You failed to conduct annual product reviews (APR) covering all the human drug products you manufacture, despite having a written and established procedure requiring them. During the inspection, an APR for only one of your nine OTC sunscreen drug product groupings had been completed.

Passage 10

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.