| Public Health Service Food and Drug Administration |
Denver District Office |
Department of Health and Human ServicesDecember 3, 2010
Ref: DEN-11-04 WL
WARNING LETTER
VIA UPS
John Carroll, Chief Executive Officer
Hain North America
50 South Service Rd.
Melville, NY 11747
Dear Mr. Carroll:
On March 31, April 1, 5, 7-9, 14, 2010, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 4600 Sleepytime Drive, Boulder, Colorado. Our investigator found a number of violations of 21 CFR Part 111, Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
The inspection revealed that your Ginseng Energy, Detox A.M., Echinacea Complete Care, Sleepytime Extra, Sleepytime Throat Tamer, and Tummy Mint herbal tea products manufactured in your facility, are adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) in that these dietary supplements have been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations for dietary supplements. These observations were presented to you in an FDA-483 at the conclusion of our inspection on April 14, 2010.
The inspection revealed the following deficiencies:
1. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, you do not have a MMR for the following “Wellness Tea” products that are labeled as herbal supplements: Ginseng Energy, Detox A.M., Echincea Complete Care, Sleepytime Extra, Sleepytime Throat Tamer, and Tummy Mint. Without a MMR, you cannot ensure each batch of your dietary supplements meet the specifications of each step in the manufacturing process including packaging and labeling of these products.
2. Your batch production records (BPR) did not include complete information relating to the production and control of each batch of your Echinacea Complete Care (b)(4) , Ginseng Energy (b)(4), Detox A.M. (b)(4), and Sleepytime Throat Tamer (b)(4) dietary supplement products, as required by 21 CFR 111.255(b). Specifically, your BPR did not include the following required information:
• 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 where this information is retained [21 CFR 111.260(c)].
• A statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)].
• Documentation, at the time of performance, of the manufacture of the batch, including the initials of the person responsible for verifying the weight or measure of each component used in the batch [21 CFR 111.260(j)(2)(ii)].
• Documentation, at the time of the performance, of packaging and labeling operations, including an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR [21 CFR 111.260(k)(2)].
• Documentation, at the time of performance, that quality control personnel reviewed the BPR, and approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement [21 CFR 111.260(l)(1) and (4).
3. You failed to establish required specifications for 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, as required by 21 CFR 111.70, for your Detox A.M., Echinacea Complete Care, Ginseng Energy, and Sleepytime Throat Tamer products. For example:
• You did not establish component specifications for each component used in the manufacture of these dietary supplements to ensure that specifications for strength are met, as required by 21 CFR 111.70(b)(2). Specifically, you did not establish strength specifications for incoming vitamins and minerals.
• You did not establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, as required by 21 CFR 111.70(g).
4. You failed to comply with requirements for laboratory operations. For example:
• You failed to verify that your laboratory examination and testing methodologies are appropriate for their intended use [21 CFR 111.320(a)]. Specifically, you did not verify that the microscopic examination process used to identify botanicals is appropriate for its intended use.
• You failed to make and keep documentation for laboratory tests and examinations including the results of the testing and examination [21 CFR 111.325(b)(2)(ii)]. Specifically, botanical identification testing for incoming raw materials is listed as “yes or no” and testing logs for E.coli and salmonella were listed as “pass/fail” and no results of data or testing were available.
• You failed to use adequate laboratory facilities to perform whatever testing and examinations are necessary to determine whether components that you use meet specifications [21 CFR 111.310(a)]. Specifically, our investigator observed that the microscope that your firm uses to examine raw material in determining whether the raw material meets specifications was not operational during the inspection.
• You failed to follow written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met [21 CFR 111.303]. Specifically, our investigator observed that, during a microbial examination for incoming botanicals, your technician did not (1) weigh the ingredients accurately when adding them to the medium, (2) grind the large material (b)(4) as listed in the SOP (b)(4) “Microbiological Plating” prior to adding it to the medium, and (3) failed to wait the appropriate time period before she used a pipette to remove the medium from the bags and place the medium onto the (b)(4). Your SOP requires the technician to shake the bag (b)(4) and let the sample sit for (b)(4). Your technician shook the bag approximately (b)(4) and immediately plated the sample onto the (b)(4).
5. Your quality control program is not adequate. For example:
• Quality control operations for components, packaging and labels before use in the manufacture of a dietary supplement must include approving and releasing from quarantine, all components, packaging, and labels before they are used, as required by 21 CFR 111.120(e). Our investigator observed that your quality control program does not have a process for approving and releasing labels and packaging.
• You do not have a system for controlling the issuance of labels, as required by 21 CFR 111.410(b). Specifically, you do not have a controlled process for the issuance of dietary supplement labels for manufacturing.
• Your quality control personnel did not review and approve decisions about whether to investigate a product complaint and review and approve the findings and follow-up action of any investigation performed, as required by 21 CFR 111.560(b). Your records revealed that your customer relations department handles and investigates product complaints and determines whether a product complaint presents a potential quality issue or safety concern.
• Your quality control operations did not periodically review all records for calibrations, inspections, and checks of automated, mechanical or electronic equipment, as required by 21 CFR 111.117(c). While reviewing your (b)(4) pre-operational inspection checklists, which document inspections conducted by your employees of various pieces of manufacturing equipment, our investigator observed that these checklists were not reviewed by your quality control personnel because these checklists were not signed by your quality control personnel, as required by 21 CFR 111.140(b)(2).
• Your quality control unit did not conduct a material review or make a disposition decision for returned dietary supplements, as required by 21 CFR 111.113(a)(5). Specifically, your firm reclaims returned product from retailers for new packaging style if a product is returned within (b)(4) of the expiration date. (b)(4). In addition, your quality control unit does not ensure that the reprocessed products meet all product specifications, as required by 21 CFR 111.525(a).
• In addition, your quality control personnel did not approve or reject the release for distribution of any returned dietary supplement that is reprocessed, as required by 21 CFR 111.525(b).
6. You did not collect representative samples of each unique lot of packaging and labels that you use to determine whether the packaging and labels meet specifications established in accordance with 21 CFR 111.70(d), as required by 21 CFR 111.80(a). Specifically, you did not collect any representative samples of labels or packaging for your Ginseng Energy, Detox A.M., Echincea Complete Care, Sleepytime Extra, Sleepytime Throat Tamer, and Tummy Mint products.
7. You failed to routinely calibrate, inspect, or check the equipment to ensure proper performance and your quality control personnel periodically failed to review these calibrations, inspections, or checks, as required by 21 CFR 111.30(c). Specifically, only (b)(4) pre-operational inspection sheets were available for review for the period from January 2010 to the end of March 2010. Of these (b)(4) records, (b)(4) of the records listed that the operator was unable to inspect the equipment. Further, there is no documentation to show that these pre-operational inspection sheets were reviewed by your quality control unit.
8. You failed to ensure that each person engaged in the manufacturing, packaging, labeling or holding, or in performing any quality control operations, has the education, training, or experience to perform the person’s assigned functions, as required by 21 CFR 111.12(c). Specifically, your training records for a specific laboratory technician did not include documented training for all of the duties for which the employee was responsible. Additionally, our investigator observed that the laboratory technician was unable to match a particular ground herb to the reference slide, as required by the firm’s SOP (b)(4) “Dietary Ingredient Identity Confirmation Program.” When our investigator commented that there did not appear to be any similarities between the ground herb and the reference slide, the technician replied that the identification was based largely on (b)(4) examination.
We received your response to the FDA-483, dated May 4, 2010. In your response, you indicated that you would correct the above violations and you provided various dates by which you would correct each violation. However, you failed to provide any documentation of your changes for our review. Without appropriate documents to review, we cannot assess your corrective actions.
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and the products you market comply with the Act and its implementing regulations.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
We offer the following comments:
We note that your method for verifying that your finished batches of dietary supplements meet required product specifications for identity, purity, strength, and composition, as required by 21 CFR 111.75(c), involves testing finished product tea blends before the blends are bagged. A tea blend, before it is bagged, is more appropriately considered in-process material. A finished bagged tea product would actually be in the form in which it is presented to the consumer, that is, the bagged blend.
We also note that your procedure for collecting representative samples of in-process materials for each manufactured batch at points, steps, or stages in the manufacturing process to determine whether the in-process materials meet established specifications, as required by 21 CFR 111.80(b), involves collecting only (b)(4) sample of the blend per batch regardless of batch size. We question whether this sample size is actually a representative sample of in-process materials for each manufactured batch, as required by 21 CFR 111.80(b). You should provide justification as to why this sample size is adequate for all batch sizes, which may range from (b)(4) pounds.
Please advise this office in writing within 15 days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.
Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in this letter, please contact Carolyn A. Pinney at (303) 236-3024.
Sincerely,
/s/
H. Thomas Warwick, Jr.
Denver District Director
HTW/cap
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