MedOffice Saglik Endustri Anonim Sirketi

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 have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary (21 CFR 211.165(a) and 211.165(b)).

Passage 2

Your firm failed to perform appropriate testing on your over-the-counter (OTC) drug products, including the identity and strength of each active ingredient, prior to release and distribution into the U.S. market. This includes your **(b)(4)** cream, **(b)(4)**, and **(b)(4)** drug products.

Passage 3

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 4

Your firm failed to adequately test incoming components, including your active pharmaceutical ingredients (APIs), for identity before using the components to manufacture your drug products. Additionally, your firm released API and other components for use in drug product manufacturing based on your supplier’s certificate of analysis (COA) without establishing the reliability of your incoming component suppliers’ test analyses at appropriate intervals.

Passage 5

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 6

Your firm failed to adequately validate the manufacturing processes and qualify the equipment used to manufacture your drug products. Additionally, you failed to demonstrate that your cleaning procedure is sufficient to appropriately clean each type of equipment, including filling equipment which is shared for multiple products, including non-drug products, in a reproducible and effective manner.