The U.S. Food and Drug Administration (FDA) has inspected drug manufacturing facility, Casmara Cosmetics, S. A., at Calle Ciudad de Lira, No. 29 y 31, Paterna (Valencia), from May 29 to 31, 2017.
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.
During FDA inspection, the investigator has observed specific violations including, but not limited to, the following.
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 (21 CFR 211.165(a)).
You released your over-the-counter (OTC) drug products, such as (b)(4) lotion and (b)(4), without testing these products for the identity and strength of each active ingredient. Testing your active ingredients is essential to ensuring the drug products you manufacture meet established specifications for the chemical and microbial attributes they purport to possess.
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 establish the reliability of component supplier analysis on which you rely in lieu of certain tests through appropriate validation of the supplier's test results at appropriate intervals (21 CFR 211.84(d)(l) and (2)).
You failed to test incoming active pharmaceutical ingredients and other components used to manufacture OTC drug products to determine their identity, purity, strength, and other appropriate quality attributes. Instead, your firm relied solely on certificates of analysis from unqualified suppliers.
In addition, you manufacture some of your products using (b)(4), but did not perform an identity test for incoming shipments of this component. You failed to determine whether (b)(4) or (b)(4) was within appropriate limits according to the USP standards for (b)(4). (b)(4) contamination in pharmaceuticals has caused lethal poisoning incidents in humans worldwide.
See FDA's guidance document, Testing of (b)(4) for (b)(4), to help you meet the CGMP requirements when manufacturing drugs containing (b)(4), at (b)(4).
3. Your firm failed to follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
Your stability program is inadequate. While you have some data that supports a (b)(4) expiry, this data is insufficient because you failed to include testing for active ingredients. You also failed to demonstrate that the chemical and physical properties of your OTC drug products will remain acceptable throughout the (b)(4) expiry you claim for your products.
4. Your firm failed to establish 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)).
You have not validated the processes used to manufacture your OTC drug products. You did not perform process qualification studies, and lacked an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality.
In addition, your batch production records lacked sufficient instructions to ensure reproducibility of your manufacturing processes. Your procedures do not include defined process parameters, such as (b)(4) times, (b)(4)speeds, (b)(4), and bulk hold times. You must have adequate records to document the steps in your manufacturing processes and demonstrate that they remain in control.
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