Makra Kozmetika D.O.O.

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 conduct for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).

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. 211.84(d)(1) and 211.84(d)(2)).

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. (21 CFR 211.100(a)).

Passage 4

You failed to validate your **(b)(4)** system and monitor the quality of your **(b)(4)** to ensure it was suitable for use in the manufacture of your drug products. You also lacked procedures to maintain and monitor your **(b)(4)** system. There were no microbiological testing records provided from the point of use to ensure it consistently meets the USP **(b)(4)** monograph and appropriate microbials limits.

Passage 5

You failed to provide scientific data to demonstrate that you have validated your equipment cleaning processes. Additionally, you failed to have cleaning procedures and maintain cleaning logs for the non-dedicated **(b)(4)** and ointment filling equipment. You lack assurance that your cleaning methods will remove all residues and contaminants as well as carry over of products.

Passage 6

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 211.22(d)).

Passage 7

Your firm failed to establish a quality unit (QU). Additionally, you failed to ensure that adequate specifications were established for the drug products, **(b)(4)** and **(b)(4)** Ointment, you manufacture and to ensure each batch was tested for, and conformed to, all appropriate quality attributes before release and distribution.