Pharmaplast S.A.E.

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 (2)).

Passage 2

You failed to perform adequate identity testing for each component lot used in the production of your **(b)(4)** drug products, including ethanol, your active pharmaceutical ingredient (API). Additionally, your API, ethanol, is not tested for methanol content, and your procedures did not ensure that you test glycerin for presence of diethylene glycol (DEG) or ethylene glycol (EG). For example, you failed to test your incoming components for identity prior to manufacturing **(b)(4)** Gel, batch **(b)(4)**.

Passage 3

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

Passage 4

You failed to include all pieces of product-contact equipment used for manufacturing your drug and device products in your cleaning validation protocols and procedures. Your cleaning validation protocols and procedures did not include the transfer carriage vessels that are used for moving drug and chemical device component during manufacturing, creating a risk of cross contamination.