Amendment status not verified — confirm the current text below against the official source.
Complaints and Adverse Reactions:. 28.1 All complaints thereof concerning product quality shall be carefully reviewed and recorded according to written procedures. Each complaint shall be investigated/evaluated by the designated personnel of the company and records of investigation and remedial action taken thereof shall be maintained. 28.2. Reports of serious adverse drug reactions resulting from the use of a drug along with comments and documents shall be forthwith reported to the concerned licensing authority. 28.3 There shall be written procedures describing the action to be taken, recall to be made of the defective product.