WARNING LETTER
A-S Medication Solutions LLC. MARCS-CMS 522197 —
- Delivery Method:
- UPS
- Recipient:
-
Recipient NameWalter Hoff
- A-S Medication Solutions LLC.
2401 Commerce Drive
Libertyville, IL 60048
United States
- Issuing Office:
- Center for Drug Evaluation and Research
United States
| Public Health Service Food and Drug Administration |
| Center for Drug Evaluation and Research Silver Spring, MD 20993-0002 |
Department of Health and Human Services
WARNING LETTER
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
June 5, 2017
Walter Hoff
A-S Medication Solutions LLC.
2401 Commerce Drive
Libertyville, IL. 60048
USA
Dear Mr. Hoff:
The United States Food and Drug Administration (FDA), has manually reviewed over (b)(4) of your firm’s listing files between May 2016 and March 2017 and has identified many instances where the listing information failed to comply with the applicable requirements. Prompt action must be taken to correct these deficiencies.
Section 510 of the Federal Food, Drug, and Cosmetic Act (“FD&C Act” or the “Act”) outlines the requirements for registration and listing of drug products. Under section 510 of the Act, and 21 CFR Part 207, with some limited exceptions, firms that manufacture[1] drugs in the United States or that are offered for import into the United States must be registered with the FDA.[2] Every person who is required to register must, at the time of initial registration, list all drugs that are manufactured for commercial distribution. [3] Drug listing information also must be updated in June and December of each year.[4] Drug listing updates must include listing information for each drug manufactured for commercial distribution not previously listed with FDA, information regarding drugs for which manufacturing for commercial distribution has been discontinued; and any material changes to previously submitted drug listing information.
In May of 2016 we randomly reviewed (b)(4) of your drug listing files and identified (b)(4) submissions that failed to comply with the applicable requirements. In light of this significant error rate, FDA contacted your firm and requested a meeting to discuss the need to correct these errors. On May 19, 2016, FDA met with the CEO, Mr. Walter Hoff, and the firm’s attorney, Mr. Marc Scheineson, at FDA headquarters. During the meeting FDA provided examples of the deficiencies identified in our review. At that time, the representatives from A-S Medication Solutions LLC., agreed to take immediate action to review all of their drug listings and correct all drug listing violations.
Your firm failed to comply with this commitment and continues to be in non-compliance with its listing obligations under section 510(j) of the FD&C Act, specifically 510(j)(2) of the Act and various provisions of 21 CFR Part 207. A recent analysis of A-S Medications’ current drug listing files has revealed that the old violations have not been entirely addressed and a number of new drug listings submitted by your firm after our May 19th meeting also do not meet the listing requirements.
This chart below highlights some examples of the existing violations in your drug listing files submitted to FDA.
Drug name and NDC | Violation |
Didrex, NDC 50090-0118 | Incorrect application number referenced in the listing file. See 21 CFR Part 207.49 (a) (7) |
Extra Strength Mapap, NDC 50090-1190 | Incorrect proprietary name included in the listing file. See 21 CFR Part 207.49 (a) (3) |
Metoprolol Tartrate, NDC 54569-3788 | Incorrect quantity for the package sizes referenced in the listing file. See 21 CFR part 207.49 (a) (4) |
Doxycycline, NDC 50090-2602 | Incorrect strength of active ingredient included in the listing file. See 21 CFR Part 207.49 (a)(4) |
Hydrocodone Bitartrate and Acetaminophen, NDC 50090-1520 | Missing the drug’s DEA schedule in the listing file. See 21 CFR Part 207.49 (a) (13) |
Ziprasidone, NDC 50090-2928 | Incorrect carton label. See 21 CFR Part 207.49 (a) (15)(i);Part 207.53(d) |
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)].
Drug listing information is accessible not only to FDA but other interested parties, including consumers and healthcare professionals. The high error rate identified during our review of a subset of your listing files, and your continued failure to ensure that new listings comply with your regulatory obligations, lead us to conclude that the non-compliant listing files are not isolated only to those we have positively identified. Therefore, to protect the public from access to inaccurate drug information, all of your drug listing files will be removed from public viewing on the same date indicated on this letter, until adequate steps are taken and 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.[5]
FDA’s Drug Registration and Listing Staff does not have sufficient resources to check each of your drug listing files before the data is published, therefore none of your firm’s listing files will be made publicly available until you are able to demonstrate to FDA, and we are able to confirm, that you have implemented a process that will ensure that your listing files are being submitted correctly and in accordance with all the drug listing regulations and requirements.
Within seven working days of receipt of this letter please notify this office, in writing, of the specific steps you have and will take to promptly identify and correct each violation, to bring all of your products into compliance. Your response also should include an explanation of the specific steps you have and will take to prevent the recurrence of violations. For any steps not completed before submitting this notice, please provide the dates when such steps will be completed.
Your response should include sufficient information to allow us evaluate whether the steps you have and will take are sufficient to correct each violation and prevent the recurrence of violations. Such responses typically would include, at a minimum, a discussion of:
- How a firm reviewed, or plans to review, all current drug listings to identify those listings that need to be updated;
- How a firm corrected, or plans to correct, the identified errors (e.g., submit corrected SPL files for existing listings, delist NDCs no longer in use by submitting end marketing dates and changing marketing status to complete); and
- The plan or process a firm has implemented, or plans to implement, in order to prevent the recurrence of the violations.
Your reply should be sent to:
Tasneem Hussain, Pharm. D.
eDRLS Staff
Food and Drug Administration
10903 New Hampshire Avenue
Building 51, Room 2261
Silver Spring, MD 20993-0002
Please note manual overrides may be required when trying to submit the corrections for certain types of errors. To request the manual overrides or if you have any questions regarding the contents of this letter, please contact edrls@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations of your firm’s registration and product listing obligations or other obligations and responsibilities to ensure compliance with applicable laws and regulations administered by FDA. It is your firm’s responsibility to ensure compliance with all applicable laws and regulations administered by FDA.
Sincerely,
/S/
Paul Loebach
cc: Chicago District Office
[1] The term “manufacture” includes each step in the manufacture, preparation, propagation, compounding, or processing of a drug, including relabeling, repackaging, and salvaging activities. 21 CFR. 207.1.
[2] FD&C Act section 510(b), (c), (d), & (i) (21 U.S.C. § 360(b), (c), (d), & (i)).
[3] FD&C Act § 510(j) (1) (21 U.S.C. § 360(j) (1)); see also 21 C.F.R. 207.41.
[4] FD&C Act § 510(j) (2) (21 U.S.C. § 360(j) (2)); see also 21 CFR 207.57.
[5] 21 CFR Part 207.81(c)