1Other quality system
Distribution records do not contain the lot or control number of drug product.
Inspection Record
Family Dollar Distribution Inc. — FDA 483 Findings
Inspectors Lauren R Brady · Michael L Jones · Margaret M Annes and 2 moreThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
You did not maintain your plant in a clean and sanitary condition and keep your plant in repair.
3Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
4Contamination control
You did not exclude pests from your food plant to protect against contamination of food.
5Contamination control
You did not take effective measures to exclude pests from your plant and protect against contamination of animal food by pests.
6Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its cleaning and maintenance.
7Stability and storage
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.
8Equipment and facility
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds insects, and other vermin.
9Equipment and facility
Buildings used in the holding of a drug product are not maintained in a good state of repair.
10Contamination control
You did not hold animal food for distribution under conditions that protect against contamination and minimize deterioration.
11Equipment and facility
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
12Contamination control
You did not keep the grounds around your plant in a condition that would protect against the contamination of food.
About this record
Extracted automatically from the document US FDA published on 2022-04-15. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
