Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
  Central Region
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5707

FEI: 1000148065
3006489197

August 25, 2009

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Joseph H. Lillard, President
Washington Homeopathic Products, Inc.
33 Fairfax Street
Berkeley Springs, WV 25411

WARNING LETTER

Dear Mr. Lillard:

An inspection of your drug manufacturing facilities located in Berkeley Springs, WV at 2601 J R Hawvemale Way and 33 Fairfax Street conducted by our Food and Drug Administration (FDA) investigator from March 26-April 14, 2009, determined that you are a manufacturer of human, veterinary, and biological drug products. The inspection found significant violations from the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations (CFR), Parts 210 and 211, with regard to the manufacture of homeopathic drug products made by your facility. These deviations reported by our investigator cause your drug products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351 (a)(2)(B)].

In addition, this inspection, as well as our review of your website at the Internet address http://www.homeopathyworks.com in June 2009, also revealed that your firm is manufacturing and/or marketing unapproved drugs in violation of Sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)] and the drugs are also misbranded in violation of Sections 301(a), 502(a), 502(£)(1), and 503(b)(4) of the Act [21 U.S.C. §§ 331(a), 352(a), 352(f)(1), and 353(b)(4)].

We acknowledge receipt of your letters dated April 24, 2009, and have included comments below where appropriate. The violations we observed, include, but are not limited to, the following:

The violations cited in this letter are not intended to be an all··inclusive statement of the objectionable conditions that exist at your facility. You are responsible for investigating and determining the causes of the objectionable conditions identified above and for preventing their recurrence or the occurrence of other objectionable conditions. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. A reinspection may be necessary.

Due to the severity of the violations and the inadequate FDA-483 responses, we are requesting that you and/or your representatives come into the Baltimore District Office for a meeting and present your corrective action plan to FDA. Within five working days, please contact Randy Pack at the number below to schedule this meeting to outline the specific steps you have taken or are taking to correct these violations.

Your reply should be directed to Randy F. Pack, Compliance Officer, Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions, please do not hesitate to contact Mr. Randy F. Pack at (410) 779-5454, extension 417.

Sincerely,

/S/

Evelyn Bonnin
District Director

1 Homeopathic Pharmacopoeia Convention of the United States. Homeopathic Pharmacopoeia of the United States [Internet]. Southeastern, PA: HPCUS; 2004. Available from http://www.hpus.com/online_database/index.php.

2 The CPG states that prescription homeopathic products "must bear the prescription legend, 'Caution: Federal law prohibits dispensing without prescription,' in conformance with Section 503(b)(l) of the Act." The CPG was adopted by the agency in 1988. In 1997, Congress enacted the FDA Modernization Act (FDAMA) (Public Law 105-115); section 126 of FDAMA amended Section 503(b)(1)(4) of the Act to require that the label of a prescription drug product bear, at a minimum, the symbol "Rx only."

3 For example, one of your Aurum Iodatum products is labeled as Aurum iodatum 13x.

4 We note that the CPG also states that, if the HPUS specifies a distinction between nonprescription (OTC) and prescription status of a product based on strength (e.g., 30X), and that distinction is more restrictive than section 503(b) of the Act, the more stringent criteria i.e., the HPUS criteria) will apply. It follows from this that, if the HPUS specifies a distinction between GTC and prescription status based on strength, and that distinction is less restrictive than section 503(b) of the Act, the section 503(b) criteria will apply regardless of the HPUS distinction.

This page was posted on January 31, 2010.

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