Public Health Service Food and Drug Administration
Center for Drug Evaluation and Research Silver Spring, MD 20993-0002
VIA UNITED PARCEL SERVICE
March 23, 2016
WL # 223
Pharmaceutical Associates, Inc.
201 Delaware Street
Greenville SC 29605 USA
Dear Becky Ochenreider:
The United States Food and Drug Administration (FDA) has reviewed your firm’s listing information provided for Guaifenesin and Codeine Phosphate 100 mg/10 mg per 5 ml (NDC 0121-1775). Our review revealed the listing for this product is missing required information. Prompt action must be taken to correct this deficiency.
Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) outlines the requirements for registration and listing of drug products. The listing for Guaifenesin and Codeine Phosphate 100 mg/10 mg per 5 ml (NDC 0121-1775) must include “a copy of all labeling for such drug…”.
A review of the listing for Guaifenesin and Codeine Phosphate 100 mg/10 mg per 5 ml (NDC 0121-1775) reveals that the product’s listing does not include a copy of the label. This product’s carton label is not uploaded into the FDA’s Electronic Drug Registration and Listing System (eDRLS) as part of the drug listing file. The unique facility identifier provided on the listing SPL also does not correspond with a currently registered establishment.
Your firm failed to fulfill its listing obligations under Section 510(j) of the FD&C Act, which is a prohibited act under Section 301(p) [21 U.S.C. 360(j) and 331(p)]. In addition, your firm’s failure to fulfill its listing obligations misbrands the product under Section 502(o) of the FD&C Act. Introduction or delivery for introduction into interstate commerce of a misbranded product is a prohibited act under Section 301(a) [21 U.S.C. 352(o) and 331(a)].
Information from your firm’s registration and product listing are accessible not only to FDA, but to other interested parties, including consumers. If this product appears on FDA’s online NDC Directory, it will be removed from public viewing on the same date this letter is issued to you, until the required corrections are made. This is an effort to maintain a correct and accurate database in order to protect and promote the public health.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct this violation. Your response should include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete these corrective actions within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.
Your reply should be sent to:
Food and Drug Administration
Mail Stop HFD-300
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact firstname.lastname@example.org. Include the case identification number of #223 on all correspondence.
Finally, you should know that this letter is not intended to be an all-inclusive list of the registration violations found in your firm’s registration and product listing. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the product into compliance.