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U.S. Department of Health and Human Services

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Enforcement Actions

Universal Supplement, Inc. 1/30/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415

WARNING LETTER

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

January 30, 2012

W/L 14-12

Doris C. Hernandez, Owner
Universal Supplement, Inc.
1185 Park Center Drive, Suite 0
Vista, California 92081-8878

Dear Ms. Hernandez: 

The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, located at 1185 Park Center Drive, Suite O, Vista, California on July 14-29, 2011.The inspection revealed that you failed to comply with the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111).

These violations cause your Bee Pollen, Night Rinse, Male Formula, and Propolis products to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 342(g)(1)), in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. You can find the Act and the referenced regulations through links in FDA's homepage at www.fda.gov.

The following violations were observed during the inspection:

1. You failed to follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, you manufactured Propolis (USI# 4329) with all purpose (b)(4) instead of (b)(4) as required by the MMR.

During the inspection, you stated that the Propolis product was being recalled as necessary, and the label owner intended to correct the labels to reflect the (b)(4). However, you have not provided any records documenting the recall of the Propolis product.

2. You failed to conduct at least one appropriate test or examination to verify the identities of any component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1).

Specifically, your firm did not test or verify the identities of any dietary ingredients used in Male Formula (USI# 4261), Propolis (USI# 4329), and Night Rinse capsules (USI# 4346). Before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you have petitioned the FDA for an exemption from such testing, consistent with the requirements in 21 CFR 111.75(a)(1)(ii), and the FDA has granted such petition. Your firm has not petitioned the FDA for such an exemption.

3. You failed to establish the specifications required by 21 CFR 111.70. Specifically:

• You failed to establish component specifications, as required by 21 CFR 111.70(b), for Male Formula (USI# 4261), Propolis (USI# 4329) and Night Rinse capsules (USI# 4346).
• You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of dietary supplement for Male Formula (USI# 4261), Propolis (USI# 4329) and Night Rinse capsules (USI# 4346) [21 CFR 111.70(e)].

We also note that once you have established the above specifications, you must determine whether the specifications have been met, as required by 21 CFR 111.73.

4. You failed to include required information in your MMRs for your Night Rinse (USI# 4346), Male Formula (USI# 4261), and Propolis (USI# 4329) products, as specified in 21 CFR 111.210. Specifically:

• You must include a statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement) and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)]. However, your MMRs for your Night Rinse (USI# 4346), Male Formula (USI #4261), and Propolis (USI# 4329) products do not include this information.
• You must include written instructions, including the following: specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR; procedures for sampling and a cross-reference to procedures for tests or examinations; specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR; and, corrective action plans for use when a specification is not met [21 CFR 111.210(h)(1)-(3),(5)]. However, your MMRs for your Night Rinse (USI# 4346), Male Formula (USI# 4261), and Propolis (USI# 4329) products do not include this information.

5. You failed to include required information in your batch production records (BPRs) for your Night Rinse (USI# 4346), Male Formula (USI# 4261), and Propolis (USI# 4329) products, as specified in 21 CFR 111.260. Specifically:

• Your BPR must include the identity of the equipment and processing lines used in producing the batch [21 CFR 111.260(b)]. However, your BPRs for your Night Rinse (USI# 4346) Male Formula (USI# 4261) and Propolis (USI# 4329) products do not include this information.
• Your BPR must include the date and time of the maintenance, cleaning and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained [21 CFR 111.260(c)]. However, your BPRs for your Night Rinse (USI# 4346), Male Formula (USI# 4261), and Propolis (USI# 4329) products do not include this information.
• Your BPR must include the unique identifier that you assigned to each component and packaging used [21 CFR 111.260(d)]. However, the BPR for Night Rinse (USI# 4346) does not include the lot numbers for the ingredients and bottles used to manufacture the product. In addition, the BPRs for Propolis (USI# 4329) and Male Formula (USI# 4261)do not contain the lot numbers of the ingredients used to manufacture the product.
• Your BPR must include a statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)]. However, your BPRs for your Night Rinse (USI# 4346), Male Formula (USI# 4261), and Propolis (USI# 4329) products lack this information.
• Your BPR must include documentation, at the time of performance, of the manufacture of the batch, including the initials of the person weighing or measuring each component used in the batch, the initials of the person responsible for verifying the weight or measure of each component used in the batch, the initials of the person responsible for adding the component to the batch, and the initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)]. However, your BPRs for your Night Rinse (USI# 4346), Male Formula (USI# 4261), and Propolis (USI# 4329) products do not include any of this information.
• Your BPR must include documentation at the time of performance that quality control personnel reviewed the BPR; approved or rejected any reprocessing or repackaging; approved and released, or rejected, the batch for distribution, including any reprocessed batch; and approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement [21 CFR 111.260(1)]. However, your BPRs for your Night Rinse (USI# 4346), Male Formula (USI# 4261), and Propolis (USI# 4329) products do not include any documentation of review by quality control personnel.
• Your BPR must include documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)]. However, the "Production Record" form of your BPR for Night Rinse (USI# 4346) shows that none of the capsules that you weighed met the target weight of (b)(4) mg. There is no documentation that you conducted a material review or made a disposition decision. As required by 21 CFR 111.113(a)(1), quality control personnel must conduct a material review and make a disposition decision if a specification established in accordance with § 111.70 is not met. Your records indicate that your capsules failed to meet target weight specifications; therefore, a material review and disposition decision should have been made.

6. You failed to hold components and dietary supplements under conditions that do not lead to the mix-up, contamination, or deterioration of components and dietary supplements, as required by 2 I CFR 111.455(c). Specifically:

• You stored a glove used for cleaning, a hammer, and four different raw materials in labeled polybags together within a box labeled (b)(4). The glove and hammer could contaminate your components. In addition, storing different components together in a box labeled (b)(4) could confuse employees and lead to mix-up of components.
• Various components in labeled polybags were stored together in the same box bearing a handwritten list of the components contained inside the box. Storing different components together in the same box could cause contamination, confuse employees and lead to mix-up of components.
• Various types of finished product capsules in polybags were stored together inside the same drums. This could lead to confusion, mix-up, and contamination of dietary supplements.

7. You failed to clearly identify under a quarantine system for appropriate disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or labeling operations, as required by 21 CFR 111.370. Specifically, you discard rejected capsules in a trash can labeled (b)(4).

8. Your firm failed to follow written procedures for numerous steps in the manufacturing process. Specifically, you failed to follow written procedures for maintaining, cleaning, and sanitizing all equipment, as required by 21 CFR 111.25(c); packaging and labeling, as required by 21 CFR 111.403; personnel, as required by 21 CFR 111.8; and quality control, as required by 21 CFR 111.103. Although you provided our investigators with standard operating procedures ("SOPs'') for these steps in the manufacturing process, you did not follow these procedures. Our investigators observed the following deviations from the written procedures for your facility:

• The SOPs entitled "Packaging Line Approval," "Issuance and Documentation of Labeling Materials," "Equipment Use Logbook," "Cleaning Procedure for the Lakso Slat Counter," and "Corrective Actions By QA/QC Department" include many tasks that are to be performed by quality assurance personnel. However, you have no quality assurance personnel.
• The SOP entitled "Equipment and Utensils and Cleaning and General Maintenance" requires the use of (b)(4) water to rinse equipment and quarterly calibration of scales. However, as discussed in item 14. you have not calibrated scales used to weigh raw ingredients. You also do not use (b)(4) water.
• The SOP entitled "Facility and Grounds Maintenance" states that a "[j]anitor shall be responsible for ensuring that waste disposal and refuse are removed on a timely basis" and "[a]dequate ... plumbing shall be provided in all areas." However, your (b)(4) gallon tote used to collect waste water was last emptied in March 2010. In addition, your plumbing is not adequate. as discussed in item 9.
• The SOP entitled "Personnel Disease Control, Hygiene and Gowning" states that "[r]ubber gloves will be worn at all times during production activities . . . ." However, our investigator observed an employee touching (b)(4) for placing in bottles with bare hands.
• The SOP entitled "Personnel Training"-states "USI Personnel engaged in the manufacturing, inspection/testing, processing, packaging, labeling, holding and distribution of the nutritional products will be trained to the extent that they understand the essential requirements for performing their job functions." The SOP further states that all training "will be documented on the attached Training Record Form .... " However, as discussed in item 12, you have failed to document any training.

In addition, you failed to establish written procedures for several steps in the manufacturing process. Specifically, you failed to establish written procedures for laboratory operations, as required by 21 CFR 111.303; manufacturing operations, as required by 21 CFR 111.353; holding and distributing operations, as required by 21 CFR 111.453; and returned dietary supplements, as required by 21 CFR 111.503.

9. Your plumbing and sewage disposal systems did not meet the sanitation requirements in 21 CFR 111.15. Specifically:

• The plumbing in your physical plant is not of an adequate size or design to properly convey sewage and liquid disposable waste from your physical plant [21 CFR 111.15(f)(2)]. Specifically, your cleaning room contains a (b)(4) compartment sink that is connected to drain into a (b)(4) gallon (b)(4) with a (b)(4) operated pump that carries waste water to an adjacent (b)(4) gallon drum. When this tank is full of waste water it is pumped into a smaller container that is wheeled across the  packaging room and emptied into a (b)(4) gallon tote located in a back room. The last time you had service to empty the (b)(4) gallon tote was in March 2010, which is not adequate to properly remove this waste water from your facility. In addition, you do not have a mop sink or separate equipment to dispose of mop water. On July 25, 2011, sand and dirt residue were observed in your (b)(4) compartment sink and an employee said they had disposed of mop water in that sink. Another employee stated that mop water is also disposed in the storm drain in the parking lot located towards the rear part of your facility
• The plumbing in your physical plant is not of an adequate size or design to avoid being a source of contamination to components, dietary supplements, water supplies, or any contact surface, or creating an unsanitary condition [21 CFR 111.15(f)(3). As noted above, you wheel waste water across the packaging room. This could lead to contamination of dietary supplements or contact surfaces in the packaging room. In addition, you dispose of mop water in your (b)(4) compartment sink. This could lead to contamination of equipment or utensils that are cleaned in the (b)(4) compartment sink. In addition, on July 14, 2011, our investigators noted a decomposed smell, similar to the smell of an outhouse, in the processing area coming from the waste water.
• The plumbing in your physical plant is not of an adequate size or design to not allow backflow from, or cross connection between, piping systems that discharge waste water or sewage and piping systems that carry water used for manufacturing dietary supplements, for cleaning contact surfaces, or for use in bathrooms or hand-washing facilities [21 CFR 111.15(f)(5)]. Specifically, our investigators observed that there was a hose connected to a spigot and coiled in a white trash bin that is used to wash parts from packing and bottling equipment. There was no backflow protection device installed on the spigot to which the hose was connected. If waste water is allowed to stand in the trash bin, the hose could create an unprotected cross-connection that could lead to contamination of the firm's water supply unless there is a backflow prevention device in place.

10. You failed to hold components under appropriate conditions of temperature so that the identity, purity, strength, and composition of the components and dietary supplements are not affected, as required by 21 CFR 111.455(a). Specifically, you stored bee pollen, a component used to manufacture Bee Pollen capsules, at room temperature; however, the label affixed to the drum of (b)(4) stated that the ingredient should be refrigerated. You do not have refrigerated storage, nor do you monitor the temperature within your facility. In addition, the certificate of analysis (COA) for another component, (b)(4), which is used to manufacture Night Rinse, indicates that it should be stored at (b)(4)°C or belowHowever, this component was also stored at room temperature.

11. You failed to identify who is responsible for your quality control operations, as required by 21 CFR 111.12(b). Specifically, you have not identified anyone to be responsible for your quality control operations.

12. You failed to make and keep records for the documentation of training, including the date of the training, the type of training, and the person(s) trained, as required by 21 CFR 111.14(b)(2). Specifically, you have no training records documenting employee training.

13. You failed to ensure that your personnel maintain gloves used in handling components or dietary supplements in a clean and sanitary condition, as required by 21 CFR 111.10(b)(5). Specifically, on July 25, 2011, our investigator observed one of your employees wearing the same gloves while sweeping the production room floor, scooping empty capsules from the hopper, and returning the capsules to the bulk container to be used at another time in production.

14. You failed to calibrate instruments or controls used in manufacturing or testing a component or dietary supplement before the first use and at the frequency specified in writing by the manufacturer or at routine intervals or as necessary to ensure the accuracy and precision of the instruments, as required by 21 CFR 111.27(b)(1)-(3). Specifically, you stated to our investigator the scales in your facility, used for weighing raw material ingredients, have not been calibrated nor have results of calibration been documented. You also failed to establish and follow written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement as required under 21 CFR 111.25(a).

The above violations are not meant to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct these violations.

Failure to promptly correct the violations may result in regulatory action without further notice, such as seizure and/or injunction.

In addition to the above violations, we have the following comment. Your firm failed to follow written procedures for cleaning the physical plant, as required by 21 CFR 111.16. The SOP entitled "Cleaning of Processing Room Floors During a Production Run" states that the processing room is to be cleaned (b)(4) times:(b)(4) and at the (b)(4). We are not sure that you have a room designated as a processing room. However, you only sweep dust in the rooms in which you process your dietary supplement products once. You do this at the end of the day while processing a batch.

Please respond to this letter within 15 working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur in the future. Your response should include any documentation necessary to show corrections. If you cannot complete all corrections within 15 working days, state the reason for the delay and the date by which you will connect any remaining violations.

Your reply should be sent to the following address: Food and Drug Administration, Attention: Blake Bevill, Director Compliance Branch, 19701 Fairchild, Irvine, California 92612-2445.

Sincerely,

/s/

Alonze E. Cruse, Director
Los Angeles District