Congressman says FDA should scrutinise J&J’s manufacturing partners
pharmafile | December 21, 2010 | News story | Manufacturing and Production | BestSweet, FDA, J&J, JJ, Johnson & Johnson, McNeil, Rolaids, manufacturing compliance, recalls
The latest flurry of recalls from Johnson & Johnson has prompted additional calls for a wide-ranging investigation of the company’s manufacturing network by US regulators.
Congressman Darrell Issa wants the FDA to probe not only J&J’s own facilities but also its relationship with contract manufacturers, following last week’s recall of 13 million Rolaids packs due to contamination with wood or metal particles.
The third-party manufacturer behind the Rolaids recall has been identified as North Carolina-based company Best Sweet in a letter Issa sent to the FDA. The letter asks whether the agency was aware Best Sweet was the manufacturer in this case, and also questions whether the agency is doing enough to make J&J adhere to Good Manufacturing Practice (GMP).
J&J and the FDA had refused to identify the contract manufacturer, which makes confectionary as well as pharmaceutical products, saying that this was confidential, commercially-sensitive information.
“I am concerned about FDA’s knowledge of BestSweet’s contractual relationship with Johnson & Johnson in manufacturing Rolaids and whether or not the FDA is acting appropriately to determine if there are other similar public safety concerns about products manufactured by BestSweet,” says Issa in the letter.
He has also asked the FDA to provide its inspection record for the company’s manufacturing facility, according to a Reuters report.
Issa is the ranking Republican on the House Oversight and Government Reform Committee, and along with committee chair Edolphus Towns has been vocal in calling for transparency on the FDA’s handling of J&J’s manufacturing problems.
Meanwhile, information is still emerging about problems at J&J’s own facilities, and particularly the Fort Washington plant in Pennsylvania operated by consumer health subsidiary McNeil. This was responsible for making the 135 million-plus over-the-counter medicines recalled in April this year, the first of more than a dozen recalls announced by the company since, and remains shut down.
An inspection of the plant carried out by the FDA between October 27 and December 9 found persistent violations, including a failure to respond properly to customer complaints, poor record-keeping and weak quality control procedures. The inspection report is available here.
Phil Taylor
Related Content
GSK’s Jemperli accepted for FDA review for endometrial cancer treatment
GSK has announced that the US Food and Drug Administration (FDA) has accepted its supplemental …
FDA approves ImmunityBio’s Anktiva bladder cancer treatment
ImmunityBio has announced that the US Food and Drug Administration (FDA) has approved Anktiva (N-803, …
Roche’s Alecensa approved by FDA as lung cancer treatment
Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …
