Examples of Field Alert in a sentence
Similarly, FDA’s inspection reports frequently cite a company’s failure to document decisions about whether to conduct recalls, about whether to file Field Alert Reports or Adverse Event Reports, and about whether a manufacturing change needs to be reported to FDA prior to implementation.
If either Party has information that would require the filing of a 3-day Field Alert report under 21 CFR Section 314.81, that Party shall immediately notify the other Party.
Drug recalls (NDA/ANDA/NADA/ANADA products) – provide details for any Field Alert submitted HEALTH HAZARD ASSESSMENT: Please provide your assessment of the health risk associated with the deficiency.
The information ini- tially may be provided by telephone or other telecommunication means, with prompt written followup using Form FDA 1932 ‘‘Veterinary Adverse Drug Reaction, Lack of Effectiveness, Prod- uct Defect Report.’’ The mailing cover for these reports must be plainly marked ‘‘3-Day NADA/ANADA Field Alert Report.’’(2) Fifteen-day NADA/ANADA alert re- port—(i) Initial report.
Customer is responsible for notifying the FDA regarding any required Field Alert Report according to 21 CFR 314.81.