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4A-089A-18-H1-1
PROCEED
31-Dec-18
No
2 ESTABLISHMENT INFORMATION PROCEED
2.1 Name of Establishment
SAN JOSE DISTRICT HOSPITAL
6 APPLICAN
The undersigne
requirements a
of the Food an
2.7.0 E-mail Address: sjdhbats_78@yahoo.com Storage Practic
2.7.1 Contact Detail 1 Landline: 0437262354 undersigned ag
2.7.2 Contact Detail 2 Landline: 0437262046 application.
2.7.3 Contact Detail 3 Mobile: 09227667043
6.1 APPROV
PROCEED
Latest phot
6.1.2 Designati
6.1.3 Tax ID Nu
6.1.4.0 Type of
6.1.4.1 ID Num
6.1.4.2 Date Ex
6.2 APPLICA
Latest phot
6.2.2 Designati
6.2.3 Tax ID Nu
6.2.4.0 Type of
6.2.4.1 ID Num
6.2.4.2 Date Ex
License to Operate
I. The said establishment shall be open for business hours under the supervision of a PRC
II. The pharmacist and other allied health professionals, upon and during employment in
with any other FDA-regulated establishment (if applicable);
III. The approved and valid License to Operate shall be displayed in a conspicuous place o
IV. To change the business name of the establishment and/or brand name of products in
Food and Drug Administration, or if the FDA rules later that it is misleading;
B. That there are no changes or variations in the establishment since the last renewal o
ownership, change of business name, change of registered pharmacist, change in wareh
change in key personnel;
VII. The products we manufacture, distribute and/or sell are registered or to be registered
responsibility and/or stewardship over the product in case of liability, adverse events, and
VIII. The establishment whether for initial, renewal or automatic renewal, is still subject t
time and undertake to respond and cooperate fully with the FDA with regard to any subse
IX. Non-compliance with the requirements and/or failure to give notice to the FDA of the
other circumstances in relation to the approval of this application is a ground for revocatio
X. Any violation of the above provisions and rules and regulations will automatically be su
License to Operate.
XI. I/We make this declaration in full knowledge and awareness of Republic Act No. 3720
Food and Drug Administration Act of 2009, other allied laws and their implementing rule
WHEREFORE, the undersigned confirm the truth of our declaration and awareness of the
this application for License to Operate be granted after compliance with the Food and Dru
WAIVER
I HEREBY GRANT AUTHORITY TO THE FOOD AND DRUG ADMINISTRATI
PRIVATE RESOURCES THE AUTHENTICITY OF ALL THE INFOR
ACKNOWLEDGEME
SUBSCRIBED AND SWORN TO BEFORE ME this _______ day of ___________
Professional Regulatory
Commission:0058321
1) REYNALDO CARANDANG OZAETA
Professional Regulatory
Commission:0046721
2) NENETTE GONZALES KATIGBAK
Known to me and to me known to be the same persons who execute the application form
same is their free and voluntary act and deed. WITNESS MY HAND AND SEAL on the date
undersigned attest to have provided true and complete information in this form, and to provide complete
rements at the time of submission. The undersigned agree to strict compliance with the rules and regulations
e Food and Drug Administration (FDA), including Good Manufacturing Practice (GMP), Good Distribution and
ge Practice (GDSP), Good Pharmacy Practice (GPP), and/or Good Laboratory Practice (GLP). Further, the
rsigned agree to grant authority to the FDA to verify the truthfulness of the information provided with this
cation.
APPROVING AUTHORITY
Signature 6.1.5 Mailing Address
SAN JOSE DISTRICT HOSPITAL,
Banay-Banay 1, San Jose 4227
Batangas
6.1.1.0 Family
atest photo of applicant Name: OZAETA
6.1.1.1 First
REYNALDO
Name(s): 6.1.6.0 E-mail Address:
6.1.1.2 Middle reycozmd@yahoo.com
CARANDANG
Name: 6.1.6.1 Contact Detail 1
Designation: Owner/ General Manager/ President Landline: 0437262230
Tax ID Number: 115-804-318 6.1.6.2 Contact Detail 2
.0 Type of Gov't ID: Professional Regulatory Commission Landline: 0437262319
.1 ID Number: 0058321 6.1.6.3 Contact Detail 3
.2 Date Expiry: 23-Oct-20 Mobile: 09228171023
APPLICANT
Signature 6.2.5 Mailing Address
SAN JOSE DISTRICT HOSPITAL,
Banay-Banay 1, San Jose 4227
Batangas
6.2.2.0 Family
atest photo of applicant Name: KATIGBAK
6.2.2.1 First
NENETTE
Name(s): 6.2.6.0 E-mail Address:
6.2.2.2 Middle sjdhbatangas.pharmacy.dept@gmail.
GONZALES
Name: 6.2.6.1 Contact Detail 1
Designation: Company Pharmacist Landline: 0437262354 loc 132
Tax ID Number: 258-991-381 6.2.6.2 Contact Detail 2
.0 Type of Gov't ID: Professional Regulatory Commission Mobile: 09227667043
.1 ID Number: 0046721 6.2.6.3 Contact Detail 3
.2 Date Expiry: 14-Jun-20 Mobile: 09420261186
ment in this establishment, is/are not and will not in any way be connected
ucts in the event that there is a similar or same name registered with the
tion are the exact duplicate of the hard copy and, any discrepancy,
a ground for disapproval of application and/or the filing of legal action
gistered with FDA prior to distribution or sale, and that we assume primary
nts, and/or other public health & safety issues;
of the foregoing duties and responsibilities among others, and prays that
and Drug Administration’s requirements.
R
STRATION TO VERIFY THROUGH BOTH GOVERNMENT AND
INFORMATION AND DOCUMENTS SUBMITTED .
GEMENT
____________ 20________ at ______________________________
ulatory 23-Oct-20
58321
______________________________
ulatory 14-Jun-20
46721
______________________________
on form and this petition form, and they acknowledged to me that the
he date and place first above written.
Provide in this space a description of the
eige, semi biconvex film- product in terms of rheology, thermal, Use this space to explain how the lot
and geometry properties among others, code used on the product label is
with score on one side and as applicable; Indicate if appropriate
her side microbiological cultures present in the correctly interpreted
product
Provide in this space a description of the
product in terms of rheology, thermal, Use this space to explain how the lot
and geometry properties among others, code used on the product label is
as applicable; Indicate if appropriate
microbiological cultures present in the correctly interpreted
product
O BEITONG IMP. & EXP. CO. LTD., INDIA KAMAGONG CHEMTRADE CORP./SAN PEDRO LAGUNA
I Manufacturer, Address Address Address; 2) API Supplier, Address Address Address;
I Manufacturer, Address Address Address; 3) API Supplier, Address Address Address;
I Manufacturer, Address Address Address; 4) API Supplier, Address Address Address;
I Manufacturer, Address Address Address; 5) API Supplier, Address Address Address;
I Manufacturer, Address Address Address; 6) API Supplier, Address Address Address;
I Manufacturer, Address Address Address; 7) API Supplier, Address Address Address;
I Manufacturer, Address Address Address; 8) API Supplier, Address Address Address;
I Manufacturer, Address Address Address; 9) API Supplier, Address Address Address;
PI Manufacturer, Address Address Address; 10) API Supplier, Address Address Address;
PI Manufacturer, Address Address Address; 11) API Supplier, Address Address Address;
PI Manufacturer, Address Address Address; 12) API Supplier, Address Address Address;
Department of Health
Food and Drug Administration
APPLICATION FORM STATUS: APPLICATION FORM
GENERAL INFORMATION: PRO 1 1 0 0 0 0 0 SOURCES & CLIENTS: PRO 1 1
ESTABLISHMENT INFORMATION: PRO 1 0 0 1 1 Document Tracking Number
PRODUCT INFORMATION: PRO 1 0 0 0 1 0 0
SUPPORTING INFORMATION: PRO 1 1 0 0 0 0 0
APPLICANT INFORMATION: PRO 1 1 1 1 Description (Optional):
PAYMENT INFORMATION: 1 0 0
GENERAL INFORMATION 2 ESTABLISHMENT INFORMATION
1
1
0
30-Dec-1899 1
2.7.0 E-mail Address: sjdhbats_78@yahoo.com
2.7.1 Contact Detail 1 Landline: 0437262354
0 2.7.2 Contact Detail 2 Landline: 0437262046
0 0 2.7.3 Contact Detail 3 Mobile: 09227667043
0 1
0
1 1
Drug 1 0 HUHS
0 0 Food 0 Device
0
0 0
0 0
0
1 0
0
1 1 0
Type of Amendment: Other Amendments 0 0
Source: Add/ Delete FAL 0 License to Operate FAL 0 0
The undersigned attest to have provided true and complete information in this form, and to provide complete
requirements at the time of submission. The undersigned agree to strict compliance with the rules and regulations of
the Food and Drug Administration (FDA), including Good Manufacturing Practice (GMP), Good Distribution and Storage
Practice (GDSP), Good Pharmacy Practice (GPP), and/or Good Laboratory Practice (GLP). Further, the undersigned agree
to grant authority to the FDA to verify the truthfulness of the information provided with this application.
Signature
Signature
PETITION
I/we am/are duly authorized to affirm the following declaration on behalf of the Company:
I. The said establishment shall be open for business hours under the supervision of PRC registered professional (if applicable) or a
II. The pharmacist and other allied health professionals, upon and during employment in this establishment, is/are not and will no
III. The approved and valid License to Operate shall be displayed in a conspicuous place of the establishment;
IV. To change the business name of the establishment in the event that there is a similar or same name registered with the Food a
V. The attached electronic copy of files/documents/information of the LTO application are the exact duplicate of the hard copy an
c. That there are no unapproved changes or variations whatsoever in the establishment since the last renewal of LTO specifica
VII. The products we manufacture, distribute or sell are registered or to be registered with FDA prior to distribiution or selling;
VIII. The establishment whether for initial, renewal or automatic renewal, is still subject to inspection by FDA’s authorized represe
IX. Non-compliance
Page 26 of 42 with the requirements and/or failure to give notice to the FDA of the change in business
438416912.xlsx address,10:28:55
09/21/2019 business na
Department of Health
Food and Drug Administration
APPLICATION FORM
IX. Non-compliance with the requirements and/or failure to give notice to the FDA of the change in business address, business na
X. Any violation of the above provisions and rules and regulations will automatically be subject to the SUSPENSION/ CANCELLATIO
XI. I/We make this declaration in full knowledge and awareness of Republic Act No. 3720, as amended by Republic Act no. 9711,
WHEREFORE, the undersigned confirm the truth of our declaration and awareness of the foregoing duties and responsibilities amo
WAIVER
I HEREBY GRANT AUTHORITY TO THE FOOD AND DRUG ADMINISTRATION TO VERIFY THE AUTHENTICITY OF ALL THE DOCUMENTS
ACKNOWLEDGEMENT
SUBSCRIBED AND SWORN TO BEFORE ME this _______ day of _________________ 20________ at ________
2) _________________________
Known to me and to me known to be the same persons who execute the foregoing instrument consisting of 2 pages including th
Series of : _____________________________
1 1
1 1
1 1
1 1
1 1
1 1
1 1
1 1
1 1
1
1 1
1 1
1 1
1 1
1 1
1 1 1
None 0 None 0
1 1
1 1
1 1
1 1
1 1
1 1
1 1
1 1
1 1
1 1
0 1 0 1
01 1 01 1
None 0 None 0
1 1
1 1
1 1
1 1
1 1
0 1 0 1
01 1 01 1
None 0 None 0
1 1
1 1
1 1
1 1
1 1
0 1 0 1
01 1 01 1
None 0 None 0
1 1
1 1
and will not in any way be connected with any other FDA regulated establishment (if applicable);
rd copy and, any discrepancy/ prejudicial contents or wilful misrepresentation on any of the data therein shall be a ground
O specifically but not limited to change of location, change of ownership, change of business name, change of registered pha
selling;
ed representatives at any reasonable time and undertake to respond and cooperate fully with the FDA with regard to any
usiness
Pagename,
35 ofownership,
42 or any other circumstances in relation to the approval of this application is a ground09/21/2019
438416912.xlsx for delisting10:28:55
Department of Health
Food and Drug Administration
APPLICATION FORM
usiness name, ownership, or any other circumstances in relation to the approval of this application is a ground for delisting
no. 9711, otherwise known as the Food and Drug Administration Act of 2009, other allied laws and their implementing ru
bilities among others, and prays that this application for License to Operate be granted after compliance with the Food and
______________________________
cluding the application form, and they acknowledged to me that the same is their free and voluntary act and deed. WIT
TIN LTO ValidTrade AddTIN LTO ValidRepac AddTIN LTO ValidImpor AddTIN LTO ValidDistr AddTIN LTO Valid
1 1 1-1 1 1 1 1-1 1 1 1 1-1 1 1 1 1-1 1 1 1
APPLOTHER REQUEST PAYMENT DETAILS
Shelf-StoraPackaSuggeNo. oExpirCPR VRegistrat RegisAmenAmenAmenCerti OtherFee LRF SurchTotalOR NDate Issued
0 0 0 ### 0 ### ### ### RNW 0 0 0 ### ### ### ### ### ###