Higley Industries, 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 test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. 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

You failed to adequately test samples of your incoming components before using the components to manufacture your over-the-counter (OTC) drug products. You also relied on your suppliers’ certificate of analyses (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.

Passage 3

You failed to adequately test your incoming ethanol, used as an active ingredient, for methanol. The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document *Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol* to help you meet the CGMP requirements when manufacturing drugs containing ethanol at https://www.fda.gov/media/173005/download.

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

You failed to adequately validate your processes and qualify the equipment used to manufacture your PSSI E-SAN Alcohol Antiseptic 80% Topical Solution Hand Sanitizer. During the inspection, you told the investigator that any filling line could be used to manufacture hand sanitizer. However, you were unable to provide documentation of process validation.

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.