Inspections, Compliance, Enforcement, and Criminal Investigations

Targeted Medical Pharma, Inc. dba Physician Therapeutics 10/6/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Center for Drug Evaluation and Research
Silver Spring, MD 20993-0002 

 

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
-

 

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