Republic of the Philippines

Department of Health
FOOD AND DRUGS ADMINISTRATION
Muntinlupa City, Philippines

In re: Report of Violation dated

30th May 2016 submitted
By the Regional Field Office VII

FDA CASE NO. 2017-0599

For: Violation of Sec. VII (B) of

AO 2016-0003, in relation to
Sec.11 (K) of
RA 3720, as amended by RA
9711

MARIANITO ALEMANIA,
Owner,
MADELICIOUS BAKESHOP
Poblacion Ubos, Loay, Bohol,
Respondent

ANSWER

COMES NOW, respondent MARIANITO D. ALEMANIA, through the

undersigned counsel and unto this Honorable Office, most respectfully alleges
that:

1. That the Respondent admits the Report of Violation submitted by the

Regional Field Office VII, showing that there was a violation of Section IV (B) of
AO 2016-0003, in relation to Sec.11 (k) of Republic Act No. 3720 as amended by
RA 9711, for operating as Food Manufacturer without a License to Operate
(LTO) from the FDA;

2. That because of this violation, Food and Drugs Administration through it

Regional Field Office VII issued a summons, FDA CASE NO. 2017-0599, DTN
20160803144025 directing the above-mentioned establishment to Cease and
Desist from operating until it can show to the Honorable Office that it has already
secure a License to Operate from the FDA;

AFFIRMATIVE DEFENSES

As affirmative defenses, the Respondent alleges the following:

 1. That Madelicious Bakeshop Loay branch is located at the southern part
of Bohol, more or less 18 kilometers from Tagbilaran City, Bohol. Upon receiving
the Summons, the staff of the bakeshop didn’t fully understand the contents and
its consequences if they fail to answer the summons within the 10-days
reglementary period. As a result, they forwarded it to their main branch in Iligan
City for further action. Unfortunately, the 10-day period had already lapsed before
the main branch instructed them to look for a lawyer to answer the Summons.

2. That the above-mentioned establishment had already processed their

License to Operate and paid the required fees; That they are waiting for the
FDA to issue the said license. Attached herein is the Order of Payment to the
Food and Drug Administration and the Payment Slip;

3. That the above-mentioned establishment ceased and desist its

production, however, they continue to display breads produced by other
Madelicious branches and other foods and beverages as per advice by the FDA
Regional Field Office;

4. That the above-mentioned establishment is religiously complying any

requirements coming from the government and due to inadvertent delay,
excusable neglect, and lack of knowledgeable personnel regarding the matter
they failed to comply on time the required License to Operate;

PRAYER

WHEREFORE, foregoing considered it is prayed of this Honorable Office

that the order directing Madelicious Loay Branch to Cease and Desist from
operation shall be lifted.

Other relief and remedies consistent with justice are also prayed for.
September 6, 2018, Tagbilaran City, Philippines.

SHERLITO M. COLUMNAS JR
Counsel for the Respondent
PIQUERO LAW OFFICE
51 REMOLADOR St., Tagbilaran City, Bohol
PTR No. 4281060-06/14/18; IBP Lifetime No. 02213;
Roll No. 40853; NCS No. 2018-63
Attorney’s Roll No. 70656
MCLE Compliance No. EXEMPTED
 VERIFICATION

I, MARIANITO D. ALEMANIA, duly represented by his attorney-in-fact,

JOCELYN S. BALISTA, Filipino, of legal age, and a resident of Macapagal
Avenue, Camague Highway, Tubod, Iligan City, Philippines after being duly
sworn in accordance with law, depose and state, that:

1. I am the owner of Madelicious Bakeshop and the Respondent in

the above-entitled case;

2. I filed this Answer in connection with the Summons with preventive

measures order filed against us by the Food and Drug
Administration;

3. The allegations herein are true and correct based on my own

knowledge and existing records and documents;

JOCELYN S. BALISTA
Attorney-in-fact of the Respondent

SUBSCRIBED AND SWORN TO before me this 6 th day of September,

2018 at Tagbilaran City, Bohol. Philippines, the attorney-in-fact of the
Respondent exhibited to me her Unified Multi-Purpose ID No. 011106390654-5
issued at Tagbilaran City, Bohol, Philippines.