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The QMN Weekly Bulletin

Form 483 Round Up: FDA Flags Four Device Facilities

April 14, 2017

The FDA has cited four device firms for a range of compliance issues including inadequate test methods, production controls, and CAPA procedures.

In an inspection at Fujifilm’s Carrollton, Texas, facility in January, inspectors observed that the accuracy and reproducibility of the facility’s test methods were not established or documented. The facility was manufacturing 70 percent isopropyl alcohol USP using invalidated methods without appropriate testing. For example, gas chromatography tests were not validated to ensure accuracy.

In addition, batch production and control records did not document the accomplishment of each significant step in manufacturing, processing, packing, and holding, according to the Form 483. For example, batch records failed to include complete traceability of all components used in manufacturing 70 percent isopropyl alcohol USP.

Life Science Outsourcing: During a June 2016 inspection of Life Science Outsourcing’s Brea, Calif., facility, inspectors found that procedures for identifying, investigating, correcting, and implementing corrective actions had not been implemented. For example, the company initiated four CAPA reports pertaining to mislabeled products. The CAPAs were closed as effective but failed to identify the cause or correct the mislabeling. Life Science continued to receive customer complaints regarding labeling issues.

The Form 483 also said certain processes were not validated. These included a cleaning step conducted during manufacturing, and a visual inspection method used to inspect finished products — including sterile surgical and implantable products — for particulate matter.

The facility did not have proper complaint review procedures were not established, including a procedure requiring investigation to identify the root cause of complaints and implement corrective actions. For example, the wrong label was printed for a particular lot of products, and the problem was missed during inspection. Life Science failed to identify the cause, and the complaint was closed after personnel were retrained without taking any other action to prevent recurrence.

Glatt: The FDA hit Glatt Air Techniques with a Form 483, citing failure to sanitize utensils or quarantine drug products.

In a January inspection of the devicemaker’s Parsippany, New Jersey, facility, FDA officials determined the company did not clean or sanitize equipment and utensils properly, citing “rust-like material and darkish-brown material” on washing machine surfaces. An “extensive amount” of off-white powder was found on the inside surface of a dryer lid, according to the Form 483, and because Glatt also failed to keep logbooks for the affected equipment, inspectors could not verify its usage history.

The facility did not conduct continued cleaning process verification for the equipment used for high-volume commercial products, according to the 483, and manufactured numerous products over a two-year period without verification studies for the cleaning procedures. Inspectors also found numerous containers of products produced by the company within the warehouse with a status indicator as well as a “deficient” quarantine.

Ascent Consumer Products: Ascent Consumer Products drew a Form 483 over problems with reporting, testing and complaint responses.

In a November 2016 inspection of Ascent’s Melville, New York, facility, FDA officials found the company did not prepare required reports on device safety and effectiveness. Ascent failed to conduct or request evaluation of a novel product used for nasal irrigation, according to inspectors.

The agency also faulted Ascent for failing to conduct scientific studies demonstrating the effectiveness of its filter units, or to establish procedures for identifying products during all stages of production and distribution.

The firms did not respond to requests for comment.

Remember, you have only 15 days to respond to a 483. Most of that time will go toward bringing your CAPA program into compliance. Don't waste a second trying to figure out how to communicate those plans in a way that will convince the FDA you are focused on improvement and committed to quality. Learn from those who have been there. Order your copy of Effective 483 Responses: Focus on CAPA Violations today.

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