Sklar Personal Care 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 conduct at least one test to verify the identity of each component of a drug product (21CFR 211.84(d)(1).

Passage 2

Your firm failed to adequately test your incoming components for identity before using the components to manufacture your OTC drug products. Specifically, your firm did not perform identity testing for the following raw materials: **(b)(4)**, which are used in the production of **(b)(4)** batch **(b)(4)**.

Passage 3

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

Passage 4

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 (21 CFR 211.100(a)).

Passage 5

Your firm failed to conduct process validations for all your over-the-counter (OTC) drug products, including but not limited to your **(b)(4)** products. Our investigators also found three instances of bulk lot **(b)(4)** for your **(b)(4)** due to out of specification results

Passage 6

Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22 (d)).

Passage 7

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.