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U.S. Department of Health and Human Services

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Enforcement Actions

H & L Jerch Sales, Inc. 7/19/12

  

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

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139 

WARNING LETTER
2012-DET-20

July 19, 2012


VIA UPS


Mr. Holger P. Jerch
General Manager / Owner
H & L Jerch Sales, Inc., DBA Bell Lifestyle Products, Inc.
07090 68th Street
South Haven, MI 49090


Dear Mr. Jerch:
 

 

The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement labeling and distribution facility located in South Haven, Michigan, from February 14 to March 14, 2012. During the inspection, our investigators found significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21 , Code of Federal Regulations, Part 111 (21 CFR Part 111 ). These CGMP violations cause your dietary supplement 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 the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. Our investigators' observations were noted on form FDA-483, Inspectional Observations, which was issued to you on March 14, 2012.


The inspection revealed the following violations:


1. Your firm failed to make and keep written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1).


Specifically, you provided no written procedures for quality control operations. You also failed to make and keep the following records related to quality control operations required by 21 CFR 111.140(b):


• Written documentation, at the time of performance, that quality control personnel performed the review, approval, or rejection requirements [21 CFR 111.140(b)(2)].


• Documentation of any material review and disposition decision and follow-up [21 CFR 111.140(b)(3)].


In addition, your firm failed to identify who is responsible for your quality control operations (each person who is identified must be qualified to perform quality control operations and have distinct and separate responsibilities related to performing such operations from those responsibilities that the person otherwise has), as required by 21 CFR 111.12(b). Specifically, at the time of the inspection you had not identified the employees specifically responsible for your quality control operations.


We have reviewed your response to the FDA-483 dated March 29, 2012 and your subsequent status update emails. Your March 29, 2012 response stated that you would establish and implement written procedures for quality control operations by April 30, 2012, and that you would update your response to FDA with copies of the revised SOPs. Your response is inadequate because you have not submitted your revised SOPs. You also stated that "management" conducts quality control operations. Because you did not specifically identify who is responsible for your quality control operations, we find your response inadequate. We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility.


2. Your firm failed to establish and follow written procedures to fulfill the requirements of 21 CFR Part 111, Subpart N for handling returned dietary supplements, as required by 21 CFR 111.503. Specifically, you provided no written procedures for returned dietary supplements. In addition, as required by 21 CFR 111.535(b), you failed to make and keep the following records:


• Written procedures for fulfilling the requirements of Subpart N [21 CFR 111.535(b)(1)];


• Any material review and disposition decision on a returned dietary supplement [21 CFR 111.535(b)(2)];


• The results of any testing or examination conducted to determine compliance with product specifications established under 21 CFR 111.70(e) [21 CFR 111.535(b)(3)]; and


• Documentation of the reevaluation by quality control personnel of any dietary supplement that is reprocessed and the determination by quality control personnel of whether the reprocessed dietary supplement meets product specifications established in accordance with 111.70(e) [21 CFR 111.535(b)(4)].


We have reviewed your response to the FDA-483 dated March 29, 2012 and your subsequent status update emails. Your March 29, 2012 response stated that you would establish and implement written procedures for returned dietary supplements by April 30, 2012, and that you would update your response to FDA with copies of the revised SOPs. Your response is inadequate because you have not submitted your revised SOPs. We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility.
 

3. Your firm failed to establish and follow written procedures, as required by 21 CFR 111.553, to fulfill the requirements of 21 CFR 111.560 relating to the review and investigation of product complaints, and the maintenance of records, as required by 21 CFR 111.570. Specifically, you provided no written procedures for addressing product complaints that were specific to operations at your facility.


The document that you provided to our investigators contained procedures used by your Canadian affiliate. In addition, product refund requests alleging that your dietary supplement products did not work were not always designated as product complaints.


We have reviewed your response to the FDA-483 dated March 29, 2012 and your subsequent status update emails. Your March 29, 2012 response stated that you would revise the SOP for documenting and investigating product complaints by April 30, 2012, and that you would update your response to FDA with copies of the revised SOP. Your response is inadequate because you have not submitted your revised SOP. We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility.


4. Your firm failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you provided no written procedures for holding and distributing operations.


We have reviewed your response to the FDA-483 dated March 29, 2012 and your subsequent status update emails. Your March 29, 2012 response stated that you would establish and implement written procedures for holding and distribution operations by April 30, 2012, and that you would update your response to FDA with copies of the revised SOPs. Your response is inadequate because you have not submitted your revised SOPs. We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility.


5. Your firm failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403. Specifically, on February 21, 2012, our investigator observed the packaging of Shark Liver Oil, Lot # 11273, without the establishment of written procedures or records. You must also make and keep records of the written procedures for packaging and labeling operations, as required by 21 CFR 111.430(b).


We have reviewed your response to the FDA-483 dated March 29, 2012 and your subsequent status update emails. Your March 29, 2012 response stated that you would establish and implement written procedures for packaging and labeling operations by April 30, 2012, and that you would update your response to FDA with copies of the revised SOPs. Your response is inadequate because you have not submitted your revised SOPs. We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility.
 

The above violations are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations.


You should take prompt action to correct the violations cited in this letter and prevent their recurrence. Failure to do so may result in enforcement action by FDA without further notice, including seizure and injunction.


Within fifteen (15) working days from your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections within 15 working days, please state the reason for the delay and the date by which you will complete the corrections.


Please send your written reply to this letter to Cicely N. Vaughn, Compliance Officer, U.S. Food and Drug Administration at 300 River Place, Suite 5900 Detroit, MI 48207. If you have any questions about this letter, please contact Compliance Officer Vaughn at 313-393-8297.


Sincerely,
/S/

Glenn T. Bass
District Director
Detroit District Office