If you haven’t had a chance to read the 17-page Food and Drug Administration inspection report of the McNeil Consumer Healthcare manufacturing plant in Fort Washington, Pennsylvania, you might not want to.

The inspection report contains 20 serious observations at the plant, including quality control procedures not being followed, faulty lab controls, inconsistencies and failure to investigate active ingredients creating “super potent” drugs, lack of training of temporary and contract employees, a lack of review of consumer complaints, holes in microbiological lab ceilings, thick dust caked on lab grills, cracks in glass, open bags of material spilling onto the ground, no weekly or monthly water testing samples and lack of sanitation.

If any actual sanitation was being done, those involved and allowed to comment on sanitation processes weren’t properly trained in proper cleaning and sanitation methods.

McNeil Consumer Healthcare and Johnson & Johnson do not appear to follow-up on any consumer complaints regarding their products, numerous observations cited. Specifically, “procedures describing the handling of all written and oral complaints regarding a drug product are not followed,” while Quality Control “neglects review and approval of validation protocols and is default in investigations, tracking, trending and maintenance of consumer complaint follow-up.”

During a walk-through of a microbiological laboratory, FDA inspectors observed:

• No cleaning/use log present.
• Thick dust covering the grill inside the
• Duct Tape wrapping the copper piping insulation where water samples and refrigerated media are stored.
• Incubator had a large amount of visible grey and brown dust/debris observed on the bottom of the chamber under the shelves where media-filled containers were located.
• There was a large exposed hole (gap) in the ceiling above incubator and next to the air vent in the ceiling.
• Various microbiological rooms containing laboratory equipment “not in-use” that contained dust/debris.
• “Out of Service” equipment cluttered laboratory areas, For examples, equipment “out of service” dates are as follows: water sample refrigerator dated 07/2007); pH meter (09/30/09); Shaker incubator (12/16/08); Culture incubator (May 2007)

During the walk-through of the Back Testing Room, FDA inspectors observed the following during microbiological testing of Children’s Zyrtec Sugar-Free Syrup:

• Hood had about a 6 inch silicone located on the right side upper filter.
• A very large spider-like crack on the left side of the hood plexi-glass where the gas vacuum hose was located. This vacuum hose is not used.
• The microbiologist was observed to pour media into the negative control which blocked/disrupted the flow.
• The microbiologist was observed to spray hands and items in the hood with Disinfectant-Scented Spray.
• Grills in front of the entire face of the filters were plastic and not easily sanitized/cleaned. A hood was dirty with grime in each square and missed pieces of plastic in several locations.

A McNeil spokesperson has declined to comment on the report.

The House Oversight Committee held a hearing on Thursday to examine Johnson & Johnson’s recall and discovered more discrepancies regarding Johnson & Johnson products and recalls, including a “phantom recall” back in 2009 of Motrin IB. In response to the hearing, Chairman Eldolphus Towns plans to introduce legislature giving the FDA the power to issue mandatory recalls.

“[This recall] is an issue of trust. When parents and grandparents give these medicines to their children, they want to be confident that they are not harmful. Johnson & Johnson has the duty to ensure their safety and the FDA has the duty to enforce that duty.”

“[The FDA] shouldn’t have to persuade a company to recall suspect products.”

The April 30 recall of 136 million children and infant’s medicine is the fourth involving children’s or adult Tylenol products since September 2009. The April 30 recall has now been expanded to include Lancaster and Puerto Rico plants.

According to the LA Times, tax records show the company cut 478 jobs at the Fort Washington plant from the end of 2005 to 2009. It has been suggested that the reduction in employees could be a cause of the recall – especially since the FDA inspection report cited a lack of training of employees.

Over 750 complaints have been filed on products related to the recall, with 30 deaths reported. The FDA is currently investigating the complaints, but has not said how many have been investigated, thus far.

While the FDA says the chance of being sickened from the more potent active formulations is “remote,” the agency has publicly suggested parents choose generics over the J & J / McNeil brands.