No. The GLP EIR is an internal agency document, which reflects the observations and
findings of the FDA investigator. It can not be released to anyone outside the agency until
agency action has been completed and the released copy is purged of all trade secret
information. Laboratories that disagree with portions of the EIR should write a letter,
which contains the areas of disagreement to the local FDA District Office. The laboratories
can ask that their letters accompany the EIR whenever it is requested under the Freedom of
Information Act.
