American Specialty Pharmacy, Inc. dba ASP Cares

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 perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.

Passage 2

Your firm failed to document and measure pressure differentials during operations to demonstrate proper airflow. Therefore, this indicated a lack of assurance that your firm can aseptically produce drug products in an environment that may not provide adequate protection against the risk of contamination.

Passage 3

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

Passage 4

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 5

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, 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 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 7

Your firm failed to validate your **(b)(4)** by ensuring your process can detect the highest and lowest temperature spots within the **(b)(4)** which provides valuable information on where to place your **(b)(4)** to ensure sterility of your products is achieved through the **(b)(4)**.

Passage 8

Your firm failed to validate your **(b)(4)** to ensure it can maintain adequate temperatures to achieve required depyrogenation.