2014 > Pharmagen Laboratories, Inc 10/24/14
2015-03-24 19:31
U.S. Food and Drug Administration
Protecting and Promoting Your Health
Pharmagen Laboratories, Inc 10/24/14
Department of Health and Human Services
Public Health S
Food and Drug
New England
One Montvale
4th Floor
Stoneham, MA
WARNING LETTER
CMS # 435786
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
October 24, 2014
Mr. Mackie Barch,
Chief Executive Officer
Pharmagen, Inc.
9337 Fraser Ave.
Silver Spring, MD 20901
Dear Mr. Barch:
From August 5 to August 23, 2013, U.S. Food and Drug Administration (FDA) investigators conducted an inspection
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products. =@3F/;>:37<D3AB75/B=@A=0A3@D32B6/BG=C@M@;LA=>3@/B=@A272<=BCA3>@=>3@/A3>B71B316<7?C3B=2 =>3@/B7=<A/<2B63GE3@3=0A3@D32>CBB7<5=<AB3@7:35=E<AE7B6=CB5:=D3A/<2<=BE3/@7<5A:33D31=D3@A</227B
leaning with forearms on the horizontal work bench surfaces on which aseptic operations are performed. Furthermo
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E/A7AAC32B=G=C@M@;=<C5CAB/<2
Although w3/19<=E:3253G=C@3;/7:2/B32C:G
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:=<53@7<0CA7<3AA0/A32=<B67A7<A>31B7=<7B/>>3/@AB6/BG=CE3@3>@=2C17<52@C5AB6/BD7=:/B3B63323@/:==2 /19<=E:3253AB6/B$6/@;/53<@357AB3@327BA4/17:7BGE7B6/A/=CBA=C@17<54/17:7BG=</<C/@G
A.
Compounded Drugs Under the FDCA
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I/.E67163F3;>BA1=;>=C<2322@C5A4@=;A3D3@/:93GAB/BCB=@G@3?C7@3;3<BA7413@B/7<1=<27B7=<A/@3;3B[1
>@3A1@7>B7=<A4=@7<27D72C/::G723<B7M32>/B73<BA>@7=@B=27AB@70CB7=<=41=;>=C<2322@C5AE/A@3:3D/<B4=@0=B6A31
/53<1GLA=;>:7/<13$=:71GC723$E6716E/AB63<7<3ffect.[2] During the FDA inspection, th
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B6=A32@C5AE3@3<=B3<B7B:32B=B63AB/BCB=@G3F3;>B7=<A4=@1=;>=C<2322@C5A23A1@70327<A31B7=<=4B63
/53<1GLA3F3@17A3=43<4=@13;3<B27A1@3B7=<A3B4=@B67<B63$[3]
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7<B/1B/<2A=1:/@7M32B6/BB63@3;/7<23@=4A31B7=<7<1:C27<5B63@3?C7@3;3<B=4D/:72>@3A1@7>B7=<A4=@7<27D72
/>>:71/0:37<3D3@G4323@/:8C2717/:17@1C7B
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2014 > Pharmagen Laboratories, Inc 10/24/14
2015-03-24 19:31
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the conditions set forth in section 503B of the FDCA, which include, but are not limited to, reporting serious adverse
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B.
Violations of the FDCA
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</227B7=<031/CA3B63A3>@=2C1BAE3@37<B3<2324=@1=<27B7=<AB6/B/@3<=B/;3</0:3B=A3:427/5<=A7A/< <=B;3271/:>@/1B7B7=<3@A/23?C/B327@31B7=<A1=C:2<=B03E@7BB3<4=@B63;A=B6/B/:/G;/<1=C:2CA3B63A3>@=2C
CA3A=<A3?C3<B:GB637@:/03:7<54/7:AB=03/@/23?C/B327@31B7=<A4=@B637@7<B3<232CA3A1/CA7<5B63;B=03;7A0
the FDCA.
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7<D3AB75/B=@A=0A3@D32A75<7M1/<B!$D7=:/B7=<A/BG=C@4/17:7BG1/CA7<5AC162@C5>@=2C1BAB=03/2C:B3@/B32E
(2)(B) of the FDCA.
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Insanitary Conditions Observed During FDA’s Inspections
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not wearing sleeve covers. In addition, FDA investigators observed operators leaning with forearms on the horizonta
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CGMP Violations Observed During FDA’s Inspection
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products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.1
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,=C@M@;2=3A<=B6/D34=@3/160/B16=42@C5>@=2C1B>C@>=@B7<5B=03AB3@7:3/<2=@>G@=53<4@33/>>@=>@7/ A/B7A4/1B=@G1=<4=@;/<13B=M</:A>317M1/B7=<A4=@B632@C5>@=2C1B
&
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#<C:G
7AAC32/2@/4B5C72/<13Good Manufacturing Practices — InterimGuidance for Human
Facilities under Section 503B of the FD&C Act. )<B7:M</:@35C:/B7=<A/@3>@=;C:5/B327<B3<2AB=23A1@7037BA3
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2014 > Pharmagen Laboratories, Inc 10/24/14
2015-03-24 19:31
4/17:7B73A/<2B63!$@3?C7@3;3<BA7<
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consult this draft guidance regarding particular provisions in 21 CFR Parts 210 and 211 cited above, pending the de
new regulations.
Corrective Actions
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Conclusion
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</227B7=<B=B/97<5/>>@=>@7/B31=@@31B7D3/1B7=<AG=CA6=C:2<=B74GB67A=ffi13>@7=@B=@3AC;7<5>@=2C1B7=<=4/<G
Your response should be addressed to Karen N. Archdeacon, Compliance Officer New England District: One Montv
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'7<13@3:G
'
Mutahar Shamsi
District Director
New England District
Cc:
Scott K. Morton
Executive Vice President
Pharmagen Laboratories, Inc.
30 Buxton Farms Road, Suite 110
Stamford, CT 06905
[1] Compare Western States Med. Ctr. v. Shalala, 238 F.3d 1090 (9th Cir. 2001) with Medical Ctr. Pharm. v. Mukasey,
[2](63$A3B4=@B6/<=<3F6/CAB7D3:7AB=44/1B=@AB6/B1=<A723@327<23B3@;7<7<5E63B63@B=B/933<4=@13;
</BC@3=4/>6/@;/1GA/1B7D7B73A@/7A321=<13@<A(67A$6/A033<E7B62@/E<7<:756B=4<3E:357A:/B7=<'3303:=
[3] See
)'I//5@/<B7<51=;>=C<2322@C5AAB/BCB=@G3F3;>B7=<A74/;=<5=B63@B67<5AJB632@C5>@=
723<B7M327<27D72C/:>/B73<B0/A32=<B63@3137>B=4/D/:72>@3A1@7>B7=<=@23@=@/<=B/B7=</>>@=D320GB63>@3A
>@3A1@7>B7=<=@23@B6/B/1=;>=C<232>@=2C1B7A<313AA/@G4=@B63723<B7M32>/B73<BK$/BJ@31=5<
6/D33FB3;>=@/<3=CA:G1=;>=C<232/<2;/<7>C:/B32@3/A=</0:3?C/<B7B73A=46C;/<2@C5AC>=<@3137>B=4/D/:7 723<B7M32>/B73<B4@=;/:713<A32>@/1B7B7=<3@(67AB@/27B7=</:/1B7D7BG7A<=BB63AC0831B=4B67A5C72/<13K
[4]@C5%C/:7BG/<2'31C@7BG1B$C0:71 /E
'B/B"=D
[5] See @/4BC72/<134=@<2CAB@GJ&357AB@/B7=<4=@C;/<@C5=;>=C<27<5#CBA=C@17<5/17:7B73A)<23@'31B @C5/<2=A;3B711BK313;03@
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