we are enclosing a copy of the establishment inspection report for the inspection that the U.S.Food and Drug Administration conducted at your premises on the referenced locale and date.
When the Agency concludes that an inspention is "closed"under 21CFR 20.64(d)(3),it will release a copy of the EIR tothe inspected establishment.This procedure is applicable to EIRs for inspections completed on or after April 1,1997.