TEXAS Texas Department of State Health Services,

Health and Human

Services John Hellerstedt, M.D.
Commissioner .

WARNING LETTER

October 26, 2018

MR LUIS RICARDO DELEON, OWNER License Type: Prescription Drugs - 2501

PHARM D SOLUTIONS File No: 5034
1304 SOUTH LOOP W FWY CFN: 2065008
HOUSTON, TX 77054 C.M.R.R.R. 7012-1010-0001-7892-3857

Dear Mr. Deleon:

This letter is to advise you of objectionable conditions noted during a recent inspection of
your firm located at 1304 South Loop West Freeway, Houston, Texas. These conditions
require your immediate attention. and correction. ·

Enclosed are inspectional observations (Form E-14), issued to you on August 23, 2018. The
form lists the objectionable conditions observed during the inspection of your firm by Ms.
Elizabeth Richter, State Drug and Medical Device Investigator. This inspection revealed
violations that are not in conformance with Health and Safety Code, Chapter 431, Texas
·Food, Drug and Cosmetic Act (Act) and 25 Texas Administrative . Code, §§229.419 -
229.430, Licensing of Wholesale Distributors of Prescription Drugs - Including Good
Manufacturing Practices (Rules). ·

Continued failure to comply with the Act and Rules may result in the Texas Department of
State Health Services taking necessary enforcement action, such as assessing
administrative, civil and/or criminal penalties. This letter is not intended to be an all-
inclusive list of deficienci.es at your firm. It is your responsibility to ensure adherence to
the requirements of the Act and Rules.

Please respond in writing to me, within 15 days of receipt of this letter, regarding the
objectionable conditions noted on the enclosed Form E-14. Your written response should
include (1) each step that has been or will be taken to completely correct the current
violation and prevent the recurrence of similar violations; (2) the time that the correction
will be completed; and (3) any documentation necessary to indicate corrections have been
made. ·

P.O.Box149347 • Austin,Texas78714-9347 • Phone:888-963-7111 • TIY:800~735-2889 • www.dshs.texas.gov

Pharm D Solutions LLC
October 26, 2018
page 2

If you have any questions concerning this letter, you may contact Mr. Brad O'Donnell,
Compliance Officer, at (512) 231-5734 or by e-mail at: brad.odonnell@dshs.texas.gov. For
additional information, please visit the Drugs and Medical Devices Group website at:
www.dshs.texas.gov/dmd.

Sincerely,
Mail Response to:

Megan Snyder, Manager

Drugs and Medical Devices Group MC 1987
Texas Department of State Health Services
PO Box 149347
Austin, TX 78714-9347

Enclosure: Form E-14 dated August 23, 2018 (6 pages)

cc: Drugs and Medical Devices Surveillance Section
 . ~

DEPARTMENT OF STATE HEALTH No. 06-1307

SERVICES
Date: 08/23/18
P.O. Box 149347
Austin, Texas 78714-9347

Firm Name Phann D Solutions, LLC Classification Prescription Drug

Manufacturer/ 503 B Outsourcing
Facility
Person Contacted -
Mr. Luis Ricardo De Leon
------------
Title Pharmacist-in-Charge
City Houston Address 1304 S Loop W Fwy

AN INSPECTION OF YOUR ESTABLISHMENT HAS BEEN MADE. YOUR ATTENTION IS DIRECTED

TO THE CONDITIONS OBSERVED AND NOTED BELOW:

1. There i~ no quality control unit (QCU). Specifically,

a. There is no QCU separate from production. The pharmacist is involved in
production of sterile compounded drug products and their release for distribution.
b. There are no written procedures describing the roles and responsibilities of the
QCU.
c. No written procedures have been signed as reviewed and approved by qualified
personnel.

2. Employees are not given training in the particular operations they perform as part of their
function and current good manufacturing practices (cGMPs). Specifically,
a. No employees have received cGMP training in 21 CFR parts 210 & 211.
b. Employees performing the following duties do not possess the education, training
or experience in microbiology
i. Environmental monitoring
ii. Reading of contact plates
iii. Reading of vials used in media fills
c. There is no documentation and/ or written procedures to support that staff
performing visual inspection of sterile compounded drug products have adequate
training.
i

Signature ofFin'n Representative

i/L/1 ___..... -

State Food and Drug Inspector(s)

Elizabeth Richter

Sample No. 2501-245290-S

Tit e I (If collected)

Form E-14 (revised 09) Page 1of6

 DEPARTMENT OF STATE HEALTH No. 06-1307
SERVICES
Date: 08/23/18
P.O. Box 149347
Austin, Texas 78714-9347

Firm Name Phann D Solutions, LLC Classification Prescription Drug

Manufacturer/503B Outsourcing
Facility
Person Contacted Mr. Luis Ricardo De Leon Title Pharmacist-in-Charge
City Houston Address 1304 S Loop W Fwy

AN INSPECTION OF YOUR ESTABLISHMENT HAS BEEN MADE. YOUR ATTENTION IS DIRECTED

TO THE CONDITIONS OBSERVED AND NOTED BELOW:

3. Drug product production and control records are not reviewed by the QCU to determine
compliance with all established, approved written procedures before-a batch is released or
distributed. Specifically, your firm lacks a QCU so there is no approved master batch
record and the logged formula worksheets lack the following information. For example:
a. Labeling was not reconciled for N-Acetylcysteine 10mg/5mL, lot #01032018: 18.
b. Sub-potency results received and drug released for distribution for Lipo MIC-Bl2
Compound injectable, lot #07302018 :64, compounded 07/30/2018, laboratory
results reported 08/01/2018 and distributed between 08/13 - 08/20/2018.

4. Your firm failed to follow written procedures designed to prevent microbiological

contamination of drug products purporting to be sterile. For example:
a. Visitors exceeding minimal traffic allowed in cleanroom during sterile drug
production
b. Visitors do not remove jewelry prior to cleanroom entry

5. Testing and release of compounded sterile drug products for distribution do not include
appropriate laboratory determination of satisfactory conformance to the final
specifications and identity and strength of each active ingredient pnor to release.

<w
~--~
Signature of Firm Representative State Food and Drug Inspector(s)
Elizabeth Richter

·~Irle Tit~-=-...
Sample No. 2501-245290-S
(If collected)

Fonn E-14 (revised 09) Page 2of6

 ··.I

DEPARTMENT OF STATE HEALTH No. 06-1307

SERVICES
Date: 08/23/18
P.O. Box 149347
Austin, Texas 78714-9347

Firm Name Pharm D Solutions, LLC. Classification Prescription Drug

Manufacturer/503B Outsourcing
Facility
Person Contacted Mr. Luis Ricardo De Leon Title Phannacist-in-Charge
City Houston Address 1304 S Loop W Fwy

AN INSPECTION OF YOUR ESTABLISHMENT HAS BEEN MADE. YOUR ATTENTION IS DIRECTED

TO THE CONDITIONS OBSERVED AND NOTED BELOW:

Specifically, your firm does not perform potency and endotoxin testing for each batch of
drug product. For example,
a. Oxytocin USP 30 unit in 500mL Lactated Ringers, lot #07312018:12 (24-unit
batch yield) did not have potency and endotoxin testing and was released for
distribution.

6. Laboratory controls do not include the establishment of scientifi<;ally sound and

appropriate test procedures designed to assure drug products conform to standards of .
identity, strength, quality and purity. Specifically, ydur firm does not perform visual
inspection of each lot of sterile compounded drug products for particulate matter against
a dark and light background prior to distribution.

7. Procedures designed to prevent microbiological contamination of drug products

purporting to be sterile do· not include adequate validation of the sterilization process.
Specifically, ·
a. Media fills are deficient
1. Media fills do not simulate actual aseptic operations performed or size of
batches filled
n. Media fills do not include lyophilized p~o1uct~ ~

krctJ€_{.
signature of Firm Representative
· · _Ll_l/_ \t::=_-==---
State Food and Drug Inspector(s)
Elizabeth Richter

Sample No. 2501-245290-S

(If collected)

Form E-14 (revised 09) Page 3 of6

 DEPARTMENT OF STATE HEALTH No. 06-1307
SERVICES
Date: 08/23118
P.O. Box 149347
Austin, Texas 78714-9347

Firm Name Pharm D Solutions, LLC Classification Prescription Drug

Manufacturer/503 B Outsourcing
Facility
Person Contacted Mr. Luis Ricardo De Leon Title Pharmacist-in-Charge
City Houston Address 13 04 S Loop W Fwy

AN INSPECTION OF YOUR ESTABLISHMENT HAS BEEN MADE. YOUR ATTENTION IS DIRECTED

TO THE CONDITIONS OBSERVED AND NOTED BELOW:

b. The following was observed with respect to aseptic personnel practices:

i. Leaning with forearms on ISO 5 workbench surface
11. Torso over ISO 5 workbench
111. Head· placed in ISO 5 hood during production
1v. Exit from ISO 7 cleanroom to ante room to retrieve supplies and no glove
change

8. Facilities are not designed to m1mm1ze potential contamination and/or mix-ups.

Specifically,
a. There 1s not clear demarcation of the dirty and clean side of your firm's
ante/gowning room.

9. Routine calibration and inspection of electronic equipment is not performed according to

a written program designed to assure proper performance. Specifically, your firm lacks a
written program designed to ensure proper performance of their FreeZone Console
Freeze Dryer system (Model #700611010 6L, Serial #180152696) that is used in
lyophilization of drug products such as the following:
a. Phentolamine/Papavarin/PGE (Trimix)
b. PGE/Phentolamine (Bi-Mix)

Sign'atll!e of Firm Representative State Food and rug Inspector(s)

Elizabeth Richter

Sample No. 2501-245290-S

(If collected)

Form E-14 (revised 09) Page 4of6

 DEPARTMENT OF STATE HEALTH No. 06-1307
SERVICES
Date: 08/23/18
P.O. Box 149347
Austin, Texas 78714-9347

Firm Name Phann D Solutions, LLC Classification Prescription Drug

Manufacturer/503B Outsourcing
Facility
Person Contacted Mr. Luis Ricardo De Leon Title Pharmacist-in-Charge
-------------
City Hquston Address 1304 S Loop WFwy

AN INSPECTION OF YOUR ESTABLISHMENT HAS BEEN MADE. YOUR ATTENTION rs DIRECTED

TO THE CONDITIONS OBSERVED AND NOTED BELOW:

c. Glutamine 25mg, Arginine 1Omg, Camitine 250 mg/mL (Amino Acid Mix)

IO.The reliability of your firm's suppliers' analyses has not been established at appropriate
intervals. Specifically, your firm lacks supplier management written procedures.

I I .Aseptic processing areas are deficient regarding systems for maintaining equipment used
to control aseptic conditions. For example:
a.. Your firm's smoke visualization tests (smoke studies) do not adequately reflect
your firm's actual aseptic processes. The smoke studies were not conducted under
dynamic conditions and are not reflective of typical aseptic processes and operator
manipulations.
b. Your firm's lyophilizer is located in a ISO 7 classified area
c. Disinfectant efficacy testing for disinfectants used in the ISO 5 processing areas
has not been completed

12. Your firm lacks written complaint handling procedures, · including procedures for
determining the need for full investigations and provisions for review to determine
_whether the complaint represents an adverse· event that must be submitted to the FDA.
/

Signlfulf(;of inn Representative State Food and Drug Inspector(s

Elizabeth Richter

Sample No. 2501-245290-S

Title (If collected)

Form E-14 (revised 09) Page 5of6

 DEPARTMENT OF STATE HEALTH No. 06-1307
SERVICES
Date: 08/23/18
P.O. Box 149347
Austin, Texas 78714-9347 ;;~r~
<,,~~·

Firm Name Phann D Solutions, LLC Classification Prescription Drug

Manufacturer/503B Outsourcing
Facility
Person Contacted Mr. Luis Ricardo De Leon Title Pharmacist-in-Charge
City Houston Address 1304 S Loop W Fwy

AN INSPECTION OF YOUR ESTABLISHMENT HAS BEEN MADE. YOUR ATTENTION IS DIRECTED

TO THE CONDITIONS OBSERVED AND NOTED BELOW:

13. Written procedures are not established for evaluations done at least annually and
including provisions for a review of complaints, recalls, returned products and
investigations conducted for each drug product. Specifically, your firm manufactures and
distributes compounded sterile products and no product reviews have been completed.

14.The labels of your firm's drug products are deficient. Specifically, the labels do not
include information required by section 503B(a)(10). For example:
a. The following statement "This is a compounded drug" is not included on label for
Phenol USP 5%, 10 mL vial, lot #05082018:59
b. The following information is not included on container labels:
1. Dosage form; For example: "Sodium Phosphate Buffer Solution 0.05M
30ml" (mono basic sodium phosphate 4.56mg; dibasic sodium phosphate
2.35mg; sodium chloride 430mg; sodium hydroxide in sterile water for
injection), lot# 06252018:63

Signature of Firm Representative State Food and Drug Inspector(s)

Elizabeth Richter

Sample No. 2501-245290-S

T?tle (If collected)

Form E-14 (revised 09) Page 6of6