Inspections, Compliance, Enforcement, and Criminal Investigations
Lett Us One Corporation 25-Nov-08
Department of Health and Human Services
Public Health Service
San Juan District
November 25, 2008
Return Receipt Requested
Mr. Roberto L. Romero Valdez
Lett Us One Corporation
P.O. Box 6578
Santurce, PR 00914-6578
Dear Mr. Romero:
On September 23, 24, and 26, 2008, the Food and Drug Administration (FDA) conducted an inspection of your food processing facility, located at Centro Industrial Villa Blanca, Building #3, Luis Munoz Marin Avenue, Caguas, Puerto Rico 00726. The inspection was conducted to determine compliance with FDA's Current Good Manufacturing Practice (CGMP) requirements for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). Our investigators documented serious deviations from the regulations that cause the products manufactured in your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act(the Act) [21 U.S.C. § 342(a)(3)-(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
Specifically, our inspection of your facility documented the following sanitation deviations:
To comply with 21 CFR § 110.10(b)(9), all persons working in direct contact with food, food-contact surfaces, and food packaging materials must take all necessary precautions to protect those items from contamination with microorganisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin. However, on September 23, 2008, our investigator observed the following:
a. An employee was not wearing gloves while conducting the vacuum sealing operation of bags of shredded carrots.
b. Employees were leaning over and inserting their arms into the bins containing shredded carrots and lettuce and touching, in instances, the interior of the bins with their coats and/or with broken sleeve protectors.
c. Employees did not take off their coats while using the sanitary facilities.
2. To comply with 21 CFR§ 110.10(b)(5), you must ensure that all persons working in direct contact with food maintain gloves, if used in food handling, in an intact, clean, and sanitary condition to protect against contamination of food. However, on September 23, 2008, our investigator observed employees touching non-food contact surfaces, such as their street clothes and equipment exteriors, without further sanitizing and/or changing their gloves. Further, our investigator observed employees who did not change gloves after shifting duties or at other times after their gloves might have become contaminated. For example, employees were observed placing their gloves into their coat pockets and reusing them after returning from duty breaks, including after lunch time.
3. To comply with 21 CFR § 110.10(b)(6), employees must wear, where appropriate, in an effective manner, beard covers or other effective hair restraints. However, on September 23, 2008, our investigator observed employees with beards or mustaches who were not wearing beard covers.
4. To comply with 21 CFR § 110.35(a), you must maintain buildings, fixtures, and other physical facilities of the plant in a sanitary condition and in repair sufficient to prevent food from becoming adulterated within the meaning of the Act. However, on September 23, 2008, our investigator observed the following:
a. Water condensation and rusted areas on the ceiling tiles directly above a product bin in which shredded cabbage was being processed.
b. Mold growth and water condensation on areas of the walk-in refrigerator's ceiling.
c. The walk-in refrigerator's floor was dirty and pallets stored against the walls crowded the refrigerator and obstructed the ability to properly clean the refrigerator.
5. To comply with 21 CFR §§ 110.37(d)(1) and (2), you must maintain toilet facilities in a sanitary condition and in good repair at all times. However, on September 23, 2008, our investigator observed unsanitary conditions in the toilet facilities located at the receiving/storage warehouse and in the entrance lobby, including dirty toilets and floors. Furthermore, one of the toilet's flushing systems was not working properly and some of the toilets did not drain properly.
6. To comply with 21 CFR§ 110.40(a), your plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. Furthermore, food-contact surfaces shall be corrosion-resistant when in contact with food. However, on September 23, 2008, our investigator observed rust in the equipment used to dry the shredded cabbage as well as in the equipment used to slice carrots and on the table where this equipment is located.
7. To comply with 21 CFR § 110.20, you must maintain the grounds in a condition that will protect against the contamination of food, and plant construction and design must be suitable to facilitate maintenance and sanitary operations for food-manufacturing purposes. However, on September 23, 2008, our investigator observed unsanitary conditions related to the grounds as follows:
a. Debris, vegetable remnants, deteriorated wooden pallets, dirty water, and other garbage had accumulated on the grounds outside a rolling door leading to the plant's manufacturing area.
b. The plastic curtain installed at the above-mentioned rolling door entrance was deteriorated, broken and dirty, and had rust stains and mildew growth.
This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all products marketed by your firm comply with the Act and the applicable regulations. You were previously notified of CGMP deviations by your firm, but you have failed to implement corrective and preventive action to ensure that your firm complies with the applicable FDA laws and regulations. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you have done to correct these violations. You should include in your response documentation, such as records or photographs that document the corrective and preventive actions taken by your firm, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your written reply should be addressed to the Food and Drug Administration, Attention: Carlos A. Medina, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions concerning the violations noted please contact Mr. Medina at (787) 474-9538 or by electronic mail at firstname.lastname@example.org.
Maridalia Torres Irizarry
San Juan District Office
Enclosure: FDA 483