Xtreme Tools International, 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. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 2

Your firm failed to ensure that incoming component lots were suitable for used in manufacturing your over-the-counter (OTC) topical drug products. For example, your firm used salicylic acid active pharmaceutical ingredient (API) to manufacture Okay Miami Salicylic Acid Foaming Scrub, based on a component supplier’s certificate of analysis (COA). However, you did not perform identity testing, nor did you verify your supplier’s test results at appropriate intervals.

Passage 3

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm also failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).

Passage 4

Your firm failed to conduct adequate finished product release testing for each batch of your drug products, including but not limited to, testing the identity and strength of the active ingredients, and testing for objectionable microorganisms.

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 adequately validate the manufacturing processes used in the production of your drug products, including qualifying your manufacturing equipment. Likewise, you lacked appropriate documentation of qualification, and maintenance for your **(b)(4)** water system, which is used in the manufacture of your drug products.

Passage 7

Your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacturing of drug products. For example, your QU failed to ensure:

Passage 8

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.