Omega & Delta Co., 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 perform an identity test on samples of each component lot used in the production of your drug products, including the active ingredient (i.e., isopropyl alcohol). Additionally, you relied on certificates of analysis (COAs) from suppliers and failed to establish the reliability of each of your suppliers’ COAs for component specifications and characteristics. This is a repeat observation from the 2017 FDA inspection.

Passage 3

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, and to follow all of your written production and process control procedures (21 CFR 211.100(a) and 211.100(b)).

Passage 4

You failed to adequately design your water system to ensure that it was suitable for producing water used in the formulation of your drug products. Your **(b)(4)** systems “**(b)(4)**” and “**(b)(4)**” appear to have multiple dead-legs,***2*** which can foster the development of biofilms.

Passage 5

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.