COUNTERMEASURES INC. (CMI) is a virtual manufacturing company that has a contract to supply 500 doses of recombinant anthrax vaccine to the US Department of Defense (DOD). The Government will test the vaccine in a phase I clinical trial involving military and civilian personnel. The DOD will be the Sponsor and holder of the IND under which the trial will be performed). Since it has no manufacturing facility of its own, CMI subcontracted with MEGATECH Inc. (MTI), a contract manufacturing Organization (CMO) that owns a current Good Manufacturing Practice (CGMP) – compliant manufacturing facility, to manufacture and deliver the vaccines to the Repository at the Trials-R-US (TRU) clinic with whom (DOD) has negotiated to carry out the phase I clinical trial. As the staff at TRU was receiving the vaccines that came in three pallets, they observed that one corner of one pallet had been bashed in and as they unwrapped the outside coverings, they discovered that many of the vials had been crushed and their contents spilled. The two intact pallets were moved into a walk-in temperature-controlled holding area while the third (damaged) was transferred to a separate walk-in temperature controlled area. The vaccine excipient included a rich medium with a broad buffering capacity requiring a storage temperature of 2-4oC. Four days later, the Quality control manager at TRU who had been away on a trip went into the walk-in area where the damaged pallet was being held to complete the paper work he would need to prepare his report to CMI. He immediately noted that it was quite warm in the room, obviously warmer than 10oC.

Identify the regulatory risk(s), if any, posed by the damage to one of the pallets and the reported temperature excursion. You may identify other risks too but the emphasis should be on the regulatory considerations for the product and those affected by it.