ARG Laboratories, 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 quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d)).

Passage 2

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 3

You failed to adequately test your incoming components for identity before using the components in your OTC drug products, including propylene glycol and active pharmaceutical ingredients such as octocrylene. Additionally, you relied on the certificates of analysis (COA) from your suppliers and failed to establish the reliability of each of your suppliers’ analyses at appropriate intervals.

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 production and process controls. During the inspection, you acknowledged that you did not conduct process validation studies and cleaning validation studies for your non-dedicated equipment. You also failed to validate your **(b)(4)** water system, which supplies water as a component used in your OTC drug products. When requested to provide water quality test results, you failed to provide any test results.

Passage 6

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 7

You failed to follow your written stability procedures for your OTC drug products. During the inspection you stated that you used expiration dates provided by your clients but were unable to provide documentation to support those dates.

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.