Thursday, July 28, 2016

Analysis of warning letter issued by US-FDA

An inspection took place in one of the food manufacturing facility by investigator of US-FDA. During that inspection significant violations were observed against 21 CFR part 110 regulation which causes the food product that the company manufactures to be adulterated within the meaning of Section 402 (a) (4) of Federal Food. Drug, and cosmetic act [ 21 U.S.C. 342 (a) (4)].

21 CFR part 110 here refers to current good manufacturing practices in manufacturing, packing or holding human food. 

and Section 402 (a) (4) of Federal Food. Drug, and cosmetic act [ 21 U.S.C. 342 (a) (4) says that
If the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;

Below are some of the observation which each food and pharma company shall review at theier manufacturing premises and understand how it is linked with code of federal regulations.

Observation 1- The firm failed to take effective measures so that the pest could be excluded from the processing area and to protect against the contamination of food on the premises by pests.These requirements are mentioned in 21 CFR 110.35(c) and 21 CFR 110.20 (b)(7)

21 CFR 110.35(c)
Title 21-Food and Drugs
CFR refers to Code of federal regulation
Sec.110.35 Sanitary Operations

21 CFR 110.35(c) Pest Control : No pests shall be allowed in any area of the food plant, Guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food contact surfaces, or food packaging materials. Effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. The use of insecticide or rodenticide is permitted only under precautions and restrictions that will protect against the contamination of food, food contact surfaces, and food packaging materials.

21 CFR 110.20 (b)(7) Provide, where necessary, adequate screening or other protection against pests.

Observation 2-Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food and food contact surfaces, as per 21 CFR 110.35(a) and 21 CFR 110.3(o)


Building, fixtures and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against contamination of food, food contact surfaces, or food-packaging material.

21 CFR 110.3(o)
Sanitize means to adequately treat food contact surfaces by a process that is effective in destroying vegetative cells of microorganism of public health significance, and in substantially reducing numbers of other undesirable microorganism, but without adversely affecting the product or its safety for the consumer.

Observation 3 
Lack of effective hand cleaning and sanitizing preparations, as per 21 CFR 110.37(e).

As per 21 CFR 110.37 (e) Hand washing facilities: Hand washing facilities shall be adequately and convenient and be furnished with running water at a suitable temperature. Compliance with this requirement may be accomplished by providing:

1) Hand washing and, where appropriate, hand sanitizing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands.
2) Effective hand cleaning and sanitizing preparations
3) Sanitary towel services or suitable drying devices.
4) Device or fixtures, such as water control valves, so designed and constructed to protect against recontamination of clean, sanitized hands.
5) Readily understandable sign directing employees handling unprotected food, unprotected food-packaging materials, of food contact surfaces to wash and, where appropriate, sanitize their hands before they start work, after each absence from post of duty, and when their hands may become soiled or contaminated. These sign may be posted in the processing room(s) and in all other areas where employees may handle such food, material, or surfaces.
6) Refuse receptacles that are constructed and maintained in a manner that protects against contamination of foods.
7) Rubbish and offal disposal  shall be so conveyed, stored and disposed of as to minimize the development of odor, minimise the potential for the waste becoming an attractant and harborage or breeding place for pests, and protecting against contamination of food, food contact surfaces, water supplies and ground surfaces.

If there are any query, question related to the article, readers are requested to mail their query at