Stokes Healthcare Inc. dba Epicur Pharma

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 conduct **(b)(4)** testing on **(b)(4)** used to sterilize the human drug product Fluorouracil PF. Therefore, you do not have assurance that the **(b)(4)** was integral throughout use.

Passage 2

Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 classified critical area, in that you did not include production steps that may impede airflow such as mixing drug lots in **(b)(4)** vessels. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.

Passage 3

Your firm failed to ensure an adequate contact time for your sporicidal agent used to disinfect your aseptic processing areas. According to the **(b)(4)** label, the required dwell time for **(b)(4)** is **(b)(4)**, but your firm's SOP only requires a **(b)(4)** dwell time. Further, the investigators observed that a **(b)(4)** dwell time is not always achieved during cleaning and disinfection.

Passage 4

Your firm failed to establish written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)).

Passage 5

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

Passage 6

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)).

Passage 7

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

Passage 8

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 9

Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).

Passage 10

Your firm failed to establish an adequate air supply filtered through high-efficiency particulate air filters under positive pressure in the aseptic processing areas (21 CFR 211.42(c)(10)(iii)).

Passage 11

Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).