WARNING LETTER
Targeted Medical Pharma, Inc. dba Physician Therapeutics MARCS-CMS 505528 —
- Recipient:
- Targeted Medical Pharma, Inc. dba Physician Therapeutics
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
October 6, 2016
Warning Letter
Physician Therapeutics LLC
Stephanie Pavlik
2980 Beverly Glen Circle, Suite 301
Los Angeles CA 90077 USA
Ms. Pavlik,
The United States Food and Drug Administration (FDA) has reviewed your firm’s listing information provided for several products listed by your facility as drugs and included in the table below. Our review revealed the listing for these products is missing required information. Prompt action must be taken to correct these deficiencies.
Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) outlines the requirements for registration and listing of drug products. Under section 510 of the Act, and Part 207, with some limited exceptions, firms that manufacture, prepare, propagate, compound, or process drugs in the United States or that are offered for import into the United States must be registered with the FDA. See 21 U.S.C. §§ 360(b), (c), (d), and (i). Every person who is required to register must, at the time of initial registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution. 21 U.S.C. § 360(j)(1). See also 21 C.F.R. 207.20. Drug listing information also must be updated in June and December each year. 21 U.S.C. § 360(j)(2); 21 CFR 207.21(b), 207.30. Drug listing updates must include a list of all drugs introduced into commercial distribution not previously listed with FDA, all drugs forwhich commercial distribution has been discontinued; and any changes to the previously submitted drug listing information.
In an FDA inspection of Physician Therapeutics' facility in Los Angeles, a voluntary destruction was witnessed at 2980 Beverly Glen Cir, Ste. 301, Los Angeles, CA 90077 on December 16, 2014. Your firm voluntarily destroyed all labels and empty cartons related to the products listed in the table below. Physician Therapeutics indicated at the time of inspection that it would immediately cease introducing or delivering these products into interstate commerce. You were informed at that time and in an email communication on May 13, 2015 that the drug listing files for these products must be updated to reflect that information.
Your firm failed to fulfill its listing obligations under Section 510(j) and specifically under 510(j)(2) of the FD&C Act. A failure to update drug listing files to reflect discontinuance of drug products is a prohibited act under Section 301(p) [21 U.S.C. 360(j) and 331(p)].
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.
Further, we note that information from your firm’s registration and drug product listings are accessible not only to FDA, but to other interested parties, including consumers. In an effort to maintain a correct and accurate database in order to protect and promote the public health, if the products referenced in this letter appear in FDA’s online NDC Directory, they will be removed from public viewing on the same date indicated in this letter. Information about a product may be restored to public view as part of the current NDC Directory when compliant listing filings indicate that it remains in production for commercial distribution or reflect discontinuance with a future “end marketing” date.
Your reply should be sent to:
Leyla Rahjou-Esfandiary, Pharm. D.
Drug Registration and Listing Staff
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 edrls@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of violations. 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 any violations, and take prompt actions to correct them.
Sincerely,
/S/
Paul Loebach, Director
Drug Registration and Listing Staff
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Cc: Los Angeles District Office
PRODUCTNDC | PROPRIETARYNAME | MARKETING START DATE | MARKETING END DATE |
68405-021 | Appbutamone | 7-Jul-11 | - |
68405-009 | Appbutamone-D | 7-Jul-11 | - |
68405-011 | Appformin | 7-Feb-11 | - |
68405-019 | Appformin-D | 7-Jul-11 | - |
68405-054 | Gabavale-5 | 7-May-11 | - |
68405-024 | Gabazolamine | 7-Jul-11 | - |
68405-034 | Gabazolamine-0.5 | 7-Jul-11 | - |
68405-044 | Gabazolpidem-5 | 7-Jul-11 | - |
68405-004 | Gabitidine | 7-Jul-11 | - |
68405-014 | Gaboxetine | 7-Jul-11 | - |
68405-027 | Hypertenevide-12.5 | 7-Jul-11 | - |
68405-037 | Hypertenipine | 7-Jul-11 | - |
68405-017 | Hypertensolol | 7-Jul-11 | - |
68405-070 | Lytensopril | 7-Jul-11 | - |
68405-007 | Lytensopril-90 | 7-Jul-11 | - |
68405-028 | Prazolamine | 7-Jul-11 | - |
68405-110 | Rimantalist | 7-Jul-11 | - |
68405-002 | Senophylline | 7-Jul-11 | - |
68405-033 | Sentradine | 7-Jul-11 | - |
68405-022 | Sentraflox AM-10 | 7-Jul-11 | - |
68405-012 | Sentralopram AM-10 | 7-Jul-11 | - |
68405-053 | Sentravil PM-25 | 7-Jul-11 | - |
68405-032 | Sentrazolam AM | 7-Jul-11 | - |
68405-023 | Sentrazolpidem PM-5 | 7-Jul-11 | - |
68405-043 | Sentroxatine | 17-Feb-11 | - |
68405-013 | Strazepam | 15-Feb-11 | - |
68405-580 | Therabenzaprine-60 | 15-May-11 | - |
68405-058 | Therabenzaprine-90 | 16-Feb-11 | - |
68405-158 | Therabenzaprine-90-5 | 15-Feb-11 | - |
68405-398 | Theracodeine-300 | 15-Feb-11 | - |
68405-098 | Theracodophen-325 | 8-Feb-11 | - |
68405-198 | Theracodophen-650 | 6-Mar-11 | - |
68405-498 | Theracodophen-750 | 9-Feb-11 | - |
68405-298 | Theracodophen-Low-90 | 2-Feb-11 | - |
68405-078 | Therafeldamine | 3-Mar-11 | - |
68405-680 | Therapentin-60 | 17-May-11 | - |
68405-068 | Therapentin-90 | 8-Feb-11 | - |
68405-880 | Theraprofen-60 | 19-Jul-11 | - |
68405-188 | Theraprofen-800 | 7-Feb-11 | - |
68405-088 | Theraprofen-90 | 7-Feb-11 | - |
68405-180 | Theraproxen | 19-May-11 | - |
68405-118 | Theraproxen-500 | 3-Mar-11 | - |
68405-018 | Theraproxen-90 | 5-Feb-11 | - |
68405-380 | Theratramadol-60 | 20-May-11 | - |
68405-038 | Theratramadol-90 | 4-Feb-11 | - |
68405-003 | Trazamine | 3-Feb-11 | - |
68405-016 | Trepoxen-250 | 3-Feb-11 | - |
68405-036 | Trepoxicam-7.5 | 31-Jan-11 | - |