Indiana Chem-Port

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to ensure that equipment surfaces in contact with API do not alter the quality of the API beyond the official or other established specifications.

Passage 2

You failed to ensure the equipment used in the manufacture of API is suitable for its intended use and is properly maintained. For example:

Passage 3

Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.

Passage 4

You failed to validate the manufacturing process for **(b)(4)** API. You stated you have not validated the manufacturing process for **(b)(4)** API because the batches are manufactured by customer orders. You made several changes to your manufacturing process without justification or change control. For example, you changed the amounts of **(b)(4)** water and **(b)(4)** added.

Passage 5

Failure to implement adequate process validation practices can result in insufficient understanding of process variables or failure to detect a drift in capability, which increases the risk of drug quality defects.

Passage 6

Failure to adequately validate written procedures for the cleaning and maintenance of equipment and failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of API.

Passage 7

You failed to adequately validate your cleaning process for non-dedicated manufacturing equipment as required by your Validation Master Plan. During the inspection, you did not provide written cleaning procedures for non-dedicated equipment, including your **(b)(4)** vessel, **(b)(4)**, and **(b)(4)**. Equipment operators stated they cleaned equipment without following a procedure. You lack assurance that your equipment is adequately cleaned to prevent cross-contamination from other products.

Passage 8

Failure to design a documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates.

Passage 9

You failed to implement an adequate stability program for **(b)(4)** API. For example, you lacked appropriate stability protocols. You established the current, **(b)(4)** retest date for **(b)(4)** API by testing reserve samples from one batch (batch **(b)(4)**). This batch was manufactured in 2016 and stored in the reserve sample room which is not controlled for humidity. Despite basing your retest dating on this batch, you destroyed batch records associated with batch **(b)(4)**.

Passage 10

Failure to have a quality unit that is independent of production and fulfills quality assurance (QA) and quality control (QC) duties.