McNeil’s 2000–2010 Inspection Record Shows a Mixed Bag of Compliance for its PA and PR Sites

Since mid-July, FDA has made public 483s and establishment inspection (EIR) reports from 17 inspections of McNeil facilities, showing a mixed bag of compliance over the last decade.

Although the inspection documents are public and available through FOI once proprietary information is removed, FDA only proactively releases documents when they have been frequently requested or at the agency’s discretion.

The documents cover primarily inspections at McNeil’s Fort Washington, Pennsylvania and Las Piedras, Puerto Rico facilities.

In about one-quarter of the inspections (4 of 17) there was no 483 issued.

One of these that did not result in a 483 was a directed inspection at the Fort Washington facility in February 2010 focused on a specific consumer complaint.  “No apparent significant deficiencies related to the consumer complaint” were found according to the EIR.

By contrast, complaint handling was a prominent issue in the inspection at the facility two months later, after which McNeil announced a recall of about 1,500 lots of liquid infant’s and children’s Tylenol, Motrin, Zyrtec and Benadryl, and voluntarily shut down the plant.

Another of the inspections that did not produce a 483 took place at the Las Piedras facility in 2006.  The inspection covered the quality and laboratory systems, and a specific field alert investigation.  FDA found “corrections of previous deficiencies” and no “significant objectionable conditions.”

The remaining 13 inspections produced a range of one to twenty observations each, for an average of seven per inspection.

[More on McNeil’s compliance history and similarities found at different facilities along with links to relevant documents is available for subscribers here.]