Public Health Service Food and Drug Administration
Center for Drug Evaluation and Research Silver Spring, MD 20993-0002
VIA UNITED PARCEL SERVICE
September 29, 2016
WL # 555
Wallace Cameron International Ltd.
26 Netherhall Rd Netherton International Estate
Wishaw Scotland ML2 0JC
Dear Agnes Campbell:
The United States Food and Drug Administration (FDA) has reviewed entries regarding shipments of drugs into the United States from the establishment listed above, as well as information on file with FDA concerning your establishment registration and drug listing. This review revealed that you have not fulfilled your establishment registration and drug listing obligations under the Federal Food, Drug, and Cosmetic Act (the Act). Our records indicate that you have not registered your establishment for 2016, but have continued to manufacture, prepare, propagate, compound, or process drugs that were not listed but being imported or offered for import into the United States during this time. The specific drug available in the U.S. market which is not listed with FDA is (b)(4). In a letter dated March 22, 2016, FDA notified you that your establishment was not duly registered and informed you of the steps you needed to take to become duly registered and to list your products. Our records indicate you have not availed yourself of this opportunity to register or list.
Under section 510(i)(1) of the Act (21 U.S.C. § 360(i)(1)), you are required to submit registration information annually by electronic means for each foreign establishment you own or operate that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is imported or offered for import into the United States. The failure to register in accordance with this provision is a prohibited act under Section 301(p) of the Act (21 U.S.C. § 331(p)). Your firm also 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 establishment registration and drug 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)].
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:
David E Mazyck
Office of Compliance
Center for Drug Evaluation and Research
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.
Finally, you should know that this letter is not intended to be an all-inclusive list of the 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.