Complete Response Letters
Hugel, Inc: letibotulinumtoxinA
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Apr 12, 2023
Health Service Act for letibotulinumtoxinA injection.
CRL_BLA761225_20230412:p1:s13Complete Response Letter, Mar 31, 2022
Health Service Act for letibotulinumtoxinA.
CRL_BLA761225_20220331:p1:s131. During a recent inspection of the Hugel, Inc (FEI 3012163998) manufacturing and testing facility of drug substance and drug product for this application, our field investigator conveyed deficiencies to the representative of the facility.
CRL_BLA761225_20220331:p1:s17Satisfactory resolution of these deficiencies is required before this application may be approved.
CRL_BLA761225_20220331:p1:s18U.S. Food and Drug Administration 1 Page(s) have been Withheld in Full as b4 (CCI/TS)
CRL_BLA761225_20220331:p2:s15More Complete Response Letters
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