Contaminated wipes are making headlines again, but this time the hot seat is occupied by Wisconsin-based Rockline Industries. The company's baby wipes recall marks its fifth in a decade, occurring in 2011, 2010, 2007, 2006 and 2001. The recall has ignited fresh concerns regarding the FDA's jurisdiction over wipes and wipes makers.
In an unrelated action in early 2011 by Triad Group, the company recalled all lots of its alcohol prep pads and swabs. Triad had $6 million in products seized and was shut down in April; in June the company succumbed to a consent decree with the FDA. Triad is just now beginning to show signs of regaining its footing [see related story].
The currently recalled Rockline wipes, found contaminated with bacteria, were made at the company's Springdale, AR, plant. The recall triggered an investigation by the Milwaukee Journal Sentinel, which reports that FDA inspectors discovered manufacturing anomalies in Arkansas in June 2011 as well as in 2006 and 2001.
The agency in June produced an "Establishment Inspection Report" rather than a Form 483 report presumably because the non-sterile wipes are considered cosmetic and therefore not subject to GMP regulations. By contrast, last year's wipes recall by the Triad Group involved sterile wipes; because of their use on open wounds, sterile wipes are subject to the same GMP regulations as drugs. [An email to the FDA requesting verification Dec. 29 was unanswered when this story was filed a day later.]
In Rockline's case, "the current inspection of the firm did not result in the issuance of a form FDA483---------------Inspectional Observations," according to the FDA report, which references the June 14-16, 2011, inspection and is signed by investigator Scott Ballad. "However, I discussed five items during the close-out meeting." They concern incomplete complaint investigations and stability reports, a white residue in tanks documented as "clean," production-line design problems, and missing validation documents.
Few details of the current recall are available. The Journal Sentinel reports that "the only public notice of the current recall has been an item buried deep in the FDA website"--so deep that this reporter was unable to find it.
The Rockline website, which lists Arkansas wet wipe manufacturing sites in Springfield and Blue Mountain Lake/Booneville, carried no notice of the recall as of Dec. 30.
Rockline's 2006 wipes recall came on the heels of a whistle-blower tip, according to the Journal Sentinel, which positions the FDA as remiss in required plant inspections. The whistle-blower tip was followed by an FDA visit, a company investigation to find "the mole," the eventual firing of the whistle-blowers, and a lawsuit, the story said.
FDA drives consent decree with H&P/Triad
Ex-QC inspector alleges H&P/Triad plant violations
FDA opts for "effective remedy" with Triad
Triad recall moves Form 483 to limelight
FDA, Triad stung in alcohol pad recall