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Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act. [1]
Sify Reports NASDAQ Staff Deficiency Letter CHENNAI, India--(BUSINESS WIRE)-- Sify Technologies Limited (NASDAQ Global Markets: SIFY), a leader in Managed Enterprise, Network and IT Services in ...
In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. [1]
The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
The deficiency letter advised that for the last 30 consecutive business days the bid price for the Company’s Class A ordinary shares had closed below the minimum $1.00 per share requirement for continued inclusion on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).
Three employees at a Maryland Cracker Barrel have reportedly been dismissed after staff refused to seat a group of students with special needs on Dec. 3 Superintendent of Charles County Public ...
An acknowledgement or deficiency letter is sent to all applicants indicating whether the whistleblower's application is procedurally correct. An SEC Office of the Whistleblower attorney, who conducts a full review of a covered action, generally communicates with whistleblowers who have submitted award applications under a covered action.
ZAP-70 deficiency Zeta-associated-protein 70 deficiency ZBLS Zadik–Barak–Levin syndrome: ZES Zollinger–Ellison syndrome: ZLS Zimmermann–Laband syndrome: ZS Zellweger syndrome: ZSD Zellweger spectrum disorders: ZSS Zellweger syndrome spectrum ZTTK syndrome Zhu–Tokita–Takenouchi–Kim syndrome