Inspections, Compliance, Enforcement, and Criminal Investigations
Edwards Pharmaceuticals, Inc
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New Orleans District
404 BNA Drive
Suite 500 Building 200
Nashville, TN 37217
February 8, 2010
WARNING LETTER NO. 2010-NOL-09
Delivery Signature Requested
Stone White, Vice President
Edwards Pharmaceuticals, Inc.
111 Mulberry Street
Ripley, Mississippi 38663
Dear Mr. White:
On (b)(4) FDA issued a warning letter to (b)(4) (copy enclosed). As explained in the warning letter, certain drug products (b)(4) has manufactured are new drugs which lack approved applications, as required under the Federal Food, Drug, and Cosmetic Act (the Act). Based on information obtained during the Food and Drug Administration's (FDA) inspection (b)(4) your firm contracted or otherwise arranged with (b)(4) manufacture one or more drug products which your firm distributes.
These drug products include, but are not necessarily limited to:
• Ed-Chlor Tan Caplets (Chlorpheniramine Tannate 8mg); and,
• Ed ChlorPed Pediatric Suspension Drops (Chlorpheniramine Tannate - equivalent to Chlorpheniramine Base 0.84mg in 1mL).
The above products are drugs within the meaning of Section 201 (g) of the Act, [21 United States Code (USC), Section 321 (g)] because, as demonstrated by their labeling, they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases. Further, they are "new drugs" within the meaning of Section 201 (p) of the Act [21 USC 321 (p)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under Sections 301(d) and 505(a) of the Act [21 USC 331(a), (d) and 355(a)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under either Section 505(b) or (j) of the Act [21 USC 355(b) or (j)] is in effect for the drug. Based on our information, there are no FDA-approved applications on file for these drug products.
Additionally, because the above prescription drug products are intended for conditions which are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so laymen can use these products safely for their intended uses, as described in Title 21, Code of Federal Regulations, Part 201.5 (21 CFR 201.5). Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under Section 502(f)(1) of the Act [21 USC 352(f)(1)]. Because the products lack required approved applications, they are not exempt under 21 CFR 201.115 from the requirements of Section 502(f)(1) of the Act. The introduction or delivery for introduction into interstate commerce of these products without approved new drug applications violates Sections 301(a) and (d) of the Act [21 USC 331(a) and (d)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations
which may exist in connection with your products. In particular, violations cited in this letter are
not necessarily limited to drug products manufactured by (b)(4) and may apply to all drug
products you market without FDA-approved applications. You are responsible for investigating
and determining the causes of the violations identified and for preventing their recurrence or the
occurrence of other violations. It is your responsibility to assure 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.
Further, as explained in the warning letter date (b)(4) to (b)(4) the above drug products are adulterated, within the meaning of 21 USC 351(a)(2)(B), and thus your firm may not introduce or deliver them for introduction into interstate commerce, per 21 USC 331 (a).
Within 15 working days of receipt of this letter, please notify this office in writing of the specific
steps you have taken to correct violations. Include an explanation of each step being taken to
prevent the recurrence of violations, as well as copies of related documentation. If you cannot
complete corrective action within 15 working days, state the reason for the delay and the time
within which you will complete the correction. If you no longer market the above products, your
response should indicate so, including the reasons, and the date on which, you ceased production.
Your reply should be directed to the U.S. Food and Drug Administration, Attention: Cynthia R.
Gibson, Compliance Officer, at the above address. If you have questions regarding any issue in
this letter, please contact Ms. Gibson at (251) 344-8208, extension 105.
H. Tyler Thornburg
New Orleans District