A person who is licensed to operate a food service facility may manufacture food for sale or distribution as provided in §§B, C, and E of this regulation. The person-in-charge shall ensure that before a food is manufactured in a food service facility: Plans for the manufacturing: Are submitted to the Department; Are approved in writing by the Department based on a review that indicates compliance with this regulation; Include: A list of foods proposed for manufacture; The proposed processing procedures for a food; Specifications for equipment items to be used for manufacture; Packaging and labeling information; Methods of shipment; Procedures for maintaining potentially hazardous food as set forth in Regulation .06B(7)—(13) of this chapter; and An HACCP plan in accordance with Regulation .34 of this chapter; and The facilities and equipment proposed for use in manufacturing are: Inspected by the Department; and Approved in writing by the Department based on a review that indicates compliance with this chapter. A person licensed only to operate a food service facility may not manufacture the following foods: Low-acid canned foods as defined in 21 CFR §113.3(n); Acidified foods as defined in 21 CFR §114.3(b); Hermetically sealed and ready-to-eat potentially hazardous foods that a hazard analysis indicates are associated with the outgrowth of Clostridium botulinum or Listeria monocytogenes, such as: Smoked fish; or Pasteurized crabmeat; Bottled water; or Soft drinks. The approving authority shall routinely inspect the food manufacturing conducted in the food service facility: During inspections of the retail food service facility; and At a frequency set forth in Regulation .30 of this chapter. The person-in-charge shall ensure that: All manufactured food is labeled in accordance with Regulation .12 of this chapter; and Records are: Made to allow the trace-back of distributed or sold food to the food service facility that manufactured the food; Made to identify the immediate source of the food and food ingredients stored and processed at the facility; For shell eggs, made to provide the information required in COMAR 15.04.01.03A(2)(a)—(e); Made to identify the initial distribution of the food to facilitate the segregation of food that may have become adulterated or otherwise unfit for human consumption; and Maintained at the facility for at least: 2 years for a shelf stable or preserved food; and 1 year for a fresh food.