Originitalia SRL

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 211.84(d)(2)).

Passage 2

You failed to test your incoming active pharmaceutical ingredients (API) for identity prior to manufacturing your bulk over-the counter (OTC) drug products, including **(b)(4)**. Additionally, you relied on certificates of analysis (COAs) from your suppliers to use incoming API without establishing the reliability of the specifications and characteristics of each supplier’s COAs.

Passage 3

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)).

Passage 4

You failed to perform adequate release testing for each batch of your drug product prior to distribution to the U.S. Market. You released your OTC drug product **(b)(4)**, without assay testing of the active ingredient, **(b)(4)**.

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 (21 CFR 211.100(a).

Passage 6

You failed to validate your manufacturing processes for your OTC drug products and provide assurance that you are capable of consistently manufacturing a drug product with defined quality attributes.

Passage 7

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

Passage 8

Your firm did not have adequate stability data to demonstrate that the chemical and microbiological properties of your drug products met established specifications and remain acceptable throughout their shelf-life.