Dyno Manufacturing, 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

You failed to adequately test your incoming components at high risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing of glycerin you used in manufacturing your drug products to determine its appropriate identity.

Passage 3

You failed to adequately test your incoming ethanol, used as an active ingredient, for methanol. During the inspection, you indicated that your supplier tests ethanol for methanol prior to shipment. You relied on your suppliers’ COA, and you have not established the reliability of your component suppliers’ test analyses at appropriate intervals. In addition, the supplier’s COA for ethanol did not include test results for methanol.

Passage 4

Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).

Passage 5

You failed to establish a stability testing program to support the expiry of your distributed drug products. You did not perform any stability studies for your OTC hand sanitizer and antibacterial hand soap drug products to support their assigned **(b)(4)** expiry period. Also, you did not have an approved stability program procedure at the time of inspection.

Passage 6

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 7

You failed to validate your production and process controls. You did not have assurance that you are capable of consistently manufacturing your drug product with defined quality attributes. Your firm lacked a process validation program and data to support fundamental process parameters such as mixing speed, time, and temperature.

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.