1. (a) Each manufacturer or processor must maintain complaint files relating to product safety. Each manufacturer or processor must establish and maintain procedures for receiving, reviewing, and evaluating complaints. The procedures must ensure that:

   1. (1) all complaints are processed in a uniform and timely manner;
   2. (2) oral complaints are documented upon receipt; and
   3. (3) complaints are evaluated to determine whether the complaint represents an event that must be reported to the FDA and the department.
2. (b) Each manufacturer or processor must review and evaluate all complaints to determine whether an investigation is necessary. All safety-related complaints must be investigated. If no investigation is made, the manufacturer or processor must maintain a record that includes the reason for not investigating and the name of the individual responsible for the decision.
3. (c) Any complaint about labeling or packaging not meeting specifications must be reviewed, evaluated, and investigated, unless a similar complaint has already been investigated and another investigation is not needed.

4. (d) The record of the investigation must include:

   1. (1) the name of the product;
   2. (2) the date the complaint was received;
   3. (3) the batch number and batch date of product used;
   4. (4) the name, address, and phone number of the complainant;
   5. (5) the nature and details of the complaint;
   6. (6) the dates and results of the investigation;
   7. (7) any corrective action taken; and
   8. (8) any reply to the complainant.

Source Note:The provisions of this §300.208 adopted to be effective March 31, 2026, 51 TexReg 1860.