WARNING LETTER
High Chemical Company, Div of National Generic Distributors
MARCS-CMS 576577 —
July 02, 2019
Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Mr. Nalin Parikh
Recipient Title
President
High Chemical Company, Div of National Generic Distributors
23 Mantoloking Lane
Waretown
,
NJ
08758
United States
Issuing Office:
Division of Pharmaceutical Quality Operations I
10 Waterview Blvd, 3rd FL
Parsippany
,
NJ
07054
United States
WARNING LETTER
CMS #576577
07/02/2019
VIA UPS OVERNIGHT
Mr. Nalin Parikh
President
High Chemical Company
23 Mantoloking Lane
Waretown, NJ 08758
Dear Mr. Parikh:
The U.S. Food and Drug Administration (FDA) inspected your drug
manufacturing facility, High Chemical Company, a Division of National Generic Distributors at 3901-A Nebraska Street, Levittown, Pennsylvania
,
from
December 17, 2018 to February 8, 2019
.
This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
Based
on
the
information your
firm
submitted
to
FDA's
Drug
Registration and
Listing
System,
and
the
evidence collected
during
the FDA inspection from
December
17,
2018
–
February
8,
2019,
your
firm
manufactures
and
distributes
Sarracenia
Purpurea
(Sarapin)
Distillate,
a
misbranded
drug
in
violation
of
section
301(a)
of the
FD&C Act,
21
U.S.C. 331(a).
We reviewed your
February 26, 2019, response
in detail.
During our inspection, our investigator observed specific deviations including, but not limited to, the following.
Failure to ensure that, for each batch of API, appropriate laboratory tests are conducted to determine conformance to specifications.
Your f
irm manufactures Sarapin, a non-sterile botanical-derived Active Pharmaceutical Ingredient (
API) intended for sterile injectable finished drug products
. Our inspection found that you did not perform appropriate quality control
testing prior to release
. For example, you failed to test for
strength by dry weight, residual pesticide, and heavy metals
on each batch of Sarapin API before it was released and distributed to customers. These tests ensure that consumers receive drugs with consistent strength and are free of deleterious substances.
Your
response
stated that the active ingredient has not been identified despite numerous attempts, and that assay testing cannot be performed. However, when the active ingredient cannot be identified, other tests can better characterize the material, as described in FDA’s
Botanical Drug Development Guidance for Industry
, which can be found at
https://www.fda.gov/media/93113/download
.
In response to this letter, provide:
A list of all test methods, both chemical and microbiological, along with their corresponding validation studies, and specifications that capture the active or chemical constituents and purity of your botanical drug substance prior to a lot disposition decision.
Test results obtained from testing retain samples of all drugs within expiry that have been distributed in the United States. Include test results for strength by dry weight, residual pesticide, heavy metals, and all other appropriate chemical and microbial quality attributes.
Failure to design a documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates.
You were unable to provide any data to support th
e
two-year expiration date
given to Sarapin API
distributed in
(b)(4)
.
Your
response
did not address this deficiency.
In response to this letter, provide a comprehensive assessment and corrective action and preventive action (CAPA) plan to ensure the adequacy of your stability program. Your CAPA plan should include, but not be limited to:
A SOP describing your stability program
Stability indicating methods
Stability studies for Sarapin in its container-closure system used for distributions
An ongoing stability program in which representative batches are added each year to the program to determine if the shelf-life claims remains valid
Specific attributes to be tested at each stability station
Misbranded Drugs
During the inspection, your firm
’s
representative stated that Sarracenia Purpurea (Sarapin) Distillate is sold for
use
as a
component
of the finished drug product, Sarapin for Injection, which is given intramuscularly and intended to
treat
pain and reduce inflammation.
As demonstrated by
its
intended
uses, the finished product Sarapin for Injection is a drug as
defined
in section 201(g)(1)(B) and (C) of the FD&C Act,
21
U.S.C. 321(g)(1)(B) and (C), because it is intended for use in the diagnosis, cure, mitigation,
treatment,
or prevention of disease and/or to
affect
the structure or
function
of the
body.
According
to
section
201(g)(1)(D)
of the FD&C Act, 21 U.S.C. 321(g)(1)(D), a drug also means an article intended for use as a component of a drug that is intended for
use
in the diagnosis,
cure,
mitigation, treatment, or prevention of
disease
and/or
to
affect
the
structure
or
function
of the body. As such,
your
Sarracenia
Purpurea
(Sarapin) Distillate is also a drug under section
201(g)(1)(D)
of the FD&C Act, 21 U.S.C. 321(g)(1)(D), because it is a
component
of Sarapin for Injection (the finished drug product).
Your Sarracenia
Purpurea
(Sarapin) Distillate is a misbranded drug
under
section
502(f)(1)
of the FD&C Act, 21 U.S.C. 352(f)(1),
because
its
labeling
fails to bear
adequate
directions for
use.
Section
201.122 of Title 21 of the Code of Federal Regulation (CFR) states that a
drug
in a bulk package … intended for processing … shall be exempt from the section 502(f)(1) of the FD&C
Act
,
21
U.S.C. 352(f)(1),
if
its label bears the statement, “Caution: For manufacturing, processing, or repackaging.”
The evidence indicates
that
the Sarracenia
Purpurea
(Sarapin) Distillate is sold to
compounding
pharmacies for
further
processing. However, the Sarracenia
Purpurea
(Sarapin) Distillate label
does
not contain the
caution
statement
described in 21 CFR 201.122. Therefore, the labeling of Sarracenia Purpurea (Sarapin) Distillate fails to bear
adequate
directions for
use
and,
therefore,
is
misbranded
under section
502(f)(1)
of the FD&C Act,
21
U.S.C. 352(f)(1). The introduction or delivery for introduction into
interstate
commerce of this misbranded drug violates sections 301(a) of the
FD&C
Act, 21 U.S.C. 331(a)
.
Drug Production Ceased
We acknow
ledge your
commitment
to “…close the company on or before May 31, 2019.” We also acknowledge that your firm
(b)(4)
.
In response to this letter, clarify if you intend to resume manufacturing or distributing any drugs or other API in the future. If you plan to resume manufacturing drugs for the U.S. market, notify this office prior to resuming your operations.
Conclusion
Deviations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these deviations, for determining the causes, for preventing their recurrence, and for preventing other deviations.
Correct the deviations cited in this letter promptly. Failure to promptly correct these deviations may result in legal action without further notice including, without limitation, seizure and injunction. Unresolved deviations in this warning letter may also prevent other Federal agencies from awarding contracts.
Until these deviations are corrected, we may withhold approval of pending drug applications listing your facility. We may re-inspect to verify that you have completed your corrective actions. We may also refuse your requests for export certificates.
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your deviations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to
ORApharm1_responses@fda.hhs.gov
.
Please identify your response with FEI number 2511349 and Warning Letter number 576577.
If you have any questions, contact Compliance Officer James Mason at
james.mason@fda.hhs.gov
or 570-262-0519
.
Sincerely,
/S/
Diana Amador-Toro
Program Division Director/District Director
U.S. Food and Drug Administration
OPQO Division I/New Jersey District
Content current as of:
07/23/2019
Regulated Product(s)
Drugs