Omega Tech Labs LLC

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 follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile (21 CFR 211.113(a)).

Passage 2

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 your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).

Passage 3

Your firm failed to provide data to demonstrate you have validated the manufacturing process for **(b)(4)** and qualified the manufacturing equipment used to produce this combination product. Also, your firm failed to appropriately evaluate whether the previously validated equipment cleaning procedures from 2010 remained suitable after the introduction of a new combination product, **(b)(4)**.

Passage 4

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 221.84 (d)(2)).

Passage 5

Your firm failed to perform adequate testing of incoming raw materials including active pharmaceutical ingredients and high-risk components such as glycerin. Your firm released glycerin for use in manufacturing based on a component supplier’s analysis report, although you had not established the reliability of the analysis through appropriate validation.

Passage 6

Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug product and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

Passage 7

Failure to address violations may also cause the FDA to withhold issuance of Export Certificates. The FDA may withhold approval of new applications or supplements listing your firm as a 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.