Bausch & Lomb Rochester, NY (7/17). Inspected Greenville, SC facility 5/20-6/10. QSR deviations, adulterated: Facility failed to appropriately validate the manufacturing processes utilized by its device products. For example, the facility failed to determine the proper amount of solution that should be flushed through the filling lines prior to packaging. The facility continues to have out-of-specification results in finished product testing for appropriate amounts of (purged), which is the preservative/disinfectant used in the majority of the eye care products. Portions of lots have been released when testing revealed OOS levels of (purged) in the finished product, based on limited testing performed on product until acceptable levels are found in the packaged product. The firm produced approximately (purged) lots of sterile eye care products between 3/18 and 4/10 that were aseptically filled in Class (purged) rooms later found to have paint flaking from the ceiling grids. Available documentation was inadequate to explain and justify the decision to release (purged) of these lots. The QA unit failed to respond appropriately to ongoing problems noted with paint chips in the production areas. Interim measures such as scraping of grids, additional cleaning, and covering grids with plastic strips were implemented with little or no documentation as to the evaluation of their effectiveness or impact on product quality, etc. (eye and lens care solutions and accessories); FDCA 501(h), 21CFR 820.75, 820.80(d), 820.70, 820.100 (02-ATL-32)
http://www.fda.gov/foi/warning_letters/g3422d.pdf
Perry Biomedical Corp. Riviera Beach, FL (7/22). Inspected 1/23-2/1. QSR deviations, adulterated, misbranded: Firm failed to establish its policy and objectives for, and commitment to, quality; failed to establish procedures for conducting management reviews; failed to establish a management representative(s) with executive responsibility for quality. No quality audits have been conducted and none are scheduled to assure the quality system is effective. Complaints are not defined, documented or processed in a timely manner. There are no written design control procedures or written procedures for Medical Device Reporting. The firm initiated corrective action 6/11/01 requesting that hyperbaric operators inspect the operability of the Magnatrol valves, change the inspection schedule from annually to monthly and install a full flow ball valve in line to facilitate the monthly inspection, but did not submit a written report to FDA within 10 days, etc. (hyperbaric chambers); FDCA 501(h), 502(t)(2), 21CFR 820.20(a),(b),(c),(d),(e), 820.22, 820.100(a), 820.30(a),(b),(c),(d),(e),(f),(g), 803.17, 806.10(b) (FLA-02-53)
