DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

555 Winderley Place, Suite 200 2/19/2020 - 2/28/2020*

Maitland, FL 32751 FEJNUMBER

(4 07)475 - 47 00 Fax: (4 07) 475 - 4768 3013854204

NAME AND TITLE OF INOMOUAL TO WHOM REPORT ISSUED

Paul Reid, Ph.D., President & Owner

F IRM NAME STREET ADDRESS

Maitland Labs o f Central Flo rida 797 2 Fo rest City Rd

C ITY. STATE. Z IP CODE. COUNTRY TYPE ESTABUSHM ENT INSPECTED

Orlando, FL 32810 - 290 7 503B Outsourcing Facility

This document lists observations made by the FDA representative(s) during the inspection of yotu· facility. They are inspectional
observations, and do not represent a final Agency determination regarding yom· compliance. If you have an objection regarding an
observation, or have implemented, or plan to implement, con-ective action in response to an observation, you may discuss the objection or
action with the FDA representative{s) during the inspection or submit this info,mation to FDA at the address above. If you have any
questions, please contact FDA at the phone number and address above.

DURIN G AN INSPECTION OF YOUR FIRM I OBSERVED:

OBSERVATION 1
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment
to produce aseptic conditions.

Specifically, according to your Phaimacy Technician, your firm is using non-sterile[( b ) ( 4 ) I

Disinfectant and non-sterile[( b ) (4 ) I to clean and disinfect the Cleam oom
and ISO s[( b ) ( 4) 'Flow Hood. In addition, the sterile wipes utilized during cleaning can potentially
shed paiiiculates.

OBSERVATION 2
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of
its components to meet any of its specifications whether or not the batch has been already disb'ibuted.

Specifically,
a. Your firm failed to follow your SOP #PRO-7.052 entitled, "Inspection Checks for Parenteral
Products" Section 6.4.10 which states, 'i( b ) ( 4)
I J". This failure is evidenced by your ti1m not
investigating when 93 vials ofNalbuphine HCL, l0mg/lmL, lot #20200108, compounded
1/8/20, exp: 1/30/21 [(6) (4 ~vials produced) failed visual inspection for fibers. Your firm's
Owner stated he believes the fibers were generated by the vial supplier, but no coITective or
preventative actions have been taken by the firm.

SEE REVERSE
OF THIS PAGE
EMPLOYEE(S) SIGNATURE

Jessica L Pressley, Investigato r _,_

~~--~-g.
DATE ISSUED

2/28/2020

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 1 of 5 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

555 Winde r ley Place, Suite 200 2/19/2020 - 2/2 8/2020 *

Maitland , FL 32751 FEJNUMBER

(4 07) 475-47 00 Fax: (4 07) 475-4768 3013854 20 4

NAME AND TITLE OF INOM OUAL TO WHOM REPORT ISSUED

Paul Reid, Ph.D., Pr esident & Owne r

F IRM NAME STREET A DDRESS

Maitland Lab s o f Cent r al Fl o r ida 7972 Fo r est City Rd

C ITY. STATE. Z IP CODE. COUNTRY TYPE ESTABU SHMENT INSPECTED

Or lando , FL 3281 0- 290 7 503B Outsou r cing Facility

b. On 1/8/20, during the)~4) ((6) (4) I ofNalbuphine HCL,

10mg/1 mL, lot #20200108 (D) (4 ~ vials) the ( b) {4 ) I) alerted the

[(6'. (4 ) [l(b l (4 ) repair kit and b) (4 ) kit replacement, [( b)

I
following alarms: exhaust rate too fast and door unsealed. The firm conducted maintenance of
the (6) 14) l on 1/ 13/20 which resulted in~Cbll f an (b) (4 kit being replaced on the (15) Pl}
4

~l
1
gauge replacement and flie ~ - (4) j located on the (b) (4) reparred. The firm
failed to evaluate the impact of the above listed alarms on the batch ofNalbuphine HCL,
l0mg/lmL, lot #20200108.

OBSERVATION 3
There is no written testing program designed to assess the stability characteristics of drug products.

Specifically,
a. Your firm failed to follow the appropriate stability requirements for both temperature and
humidity [{ 6) (4) I% RH-long term and (6) (4 ]% RH-accelerated) for the dmg product,
Nalbuphine HCL, l0mg/lmL, lot #20191111 R&D. As a result, your firm failed to have the
stability data to support the over 12-month expiration date applied to the commercial Nalbuphine
HCL, l0mg/lmL, lot #20200108, exp.: 1/30/21.

b. Your firm failed to perform the container closure integrity testing to ensure the adequacy of the
container closure system to maintain a sterile barTier against potential contaminants.

C. Your fnm failed to ensure that the Control Testing Laboratory's (CTL) potency method via
[( b (4 is stability indicating and can detect impurities.

Repeated FDA-483 Observationji-om 6/17119

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE Jessica L Pressley, Investigato r 2/ 28/ 2020

OF THIS PAGE
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FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 2 of 5 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

555 Winderley Place, Suite 200 2/19/2020 - 2/28/2020*

Maitland, FL 32751 FEJNUMBER

(407) 47 5- 47 00 Fax: (407) 47 5- 47 68 301385 420 4

NAME AND TITLE OF INOMOUAL TO WHOM REPORT ISSUED

Paul Reid, Ph.D., President & Owner

F IRM NAME STREET ADDRESS

Mait land Labs of Central Florida 7972 Forest City Rd

C ITY. STATE. Z IP CODE. COUNTRY TYPE ESTABUSHMENT INSPECTED

Orlando, FL 3281 0- 2907 503B Out sourcing Facility

OBSERVATION 4
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency
paiticulate air filters under positive pressure.

Specifically, your firm failed to conduct a smoke study under dynamic conditions within the ISO-5
(o) (4) low Hood[( o) -(4) I). This hood was utilized for the production ofNalbuphine
HCL, I0mg/l mL, lot #20200108.

OBSERVATION 5
Each batch of diug product pmpo1ting to be sterile and pyrogen-free is not laboratory tested to
dete1mine confo1mance to such requirements.

Specifically,

C. Your firm failed to ensure the sterility test method utilized by your firm 's Control Testing
Laboratory (CTL) is validated or verified under conditions of use utilizing your firm 's di11g
product, Nalbuphine HLC.

d. ~ ~15) ( 41[(D) (21-) (6) (4 )J) used for incubating the product sample for en dotoxin testing (b) ( )
4

(4) ) was located on top of a hand/equipment washing sink which causes vibrations and
can potential lead to the dismption of any (b) <4 >fo1med.

Rep eated FDA-483 Observationfi"om 6/17119

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE Jessica L Pre ssley, I nvestigat or 2/28/2020

OF THIS PAGE
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FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 3 of 5 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

555 Winderley Place, Suit e 200 2/19/2020 - 2/28/2020*

Mait land, FL 32751 FEJNUMBER

(407) 475 -4 700 Fax : (407) 475 -4 768 301385 420 4

NAME AND TITLE OF INOMOUAL TO WHOM REPORT ISSUED

Paul Reid, Ph . D. , President & Owner

F IRM NAME STREET ADDRESS

Mait land Labs of Cent ral Florida 7972 Forest Cit y Rd

C ITY. STATE. Z IP CODE. COUNTRY TYPE ESTABUSHMENT INSPECTED

Orlando, FL 3281 0- 2907 503B Out sourcing Facilit y

OBSERVATION 6
The labels of your outsourcing facility's diug products are deficient.

The label of your outsourcing facility's di11g product does not include info1mation required by section
503B(a)(l0)(A). Specifically, the following info1mation is not found on your diug product label:

• The established name of the di11g, specifically the salt "HCl''

• The strength, specifically the strength of the inactive ingredient, citi-ic acid (anhydi·ous), is
inconect: 0.063% vs. 0.63%
• The dosage fo1m
• The storage/handling instrnctions, specifically "Protect from light" and the storage conditions are
not consistent with the batch record: 15-30°C, 59-86°F

Example of your diu g product label that do not contain this in fo1mation:

• Nalbuphine HCl 10 mg/mL in 0.2% Saline

Repeated FDA -483 Observationji-om 6/17119

OBSERVATION 7
The container labels of your outsourcing facility's diug products are deficient.

The container of your outsourcing facility's diug product does not include info1mation required by
section 503B(a)(l0)(B). Specifically, your container does not include the following info1mation:
• The route of administration (i.e., intravenous)

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE Jessica L Pressley, I nvest igat or 2/28/2020

OF THIS PAGE
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FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 4 of 5 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

555 Winderley Place, Suite 200 2/19/2020 - 2/28/2020*

Maitland, FL 32751 FEJNUMBER

(407) 475-4700 Fax: (407) 475-4768 3013854204

NAME AND TITLE OF INOMOUAL TO WHOM REPORT ISSUED

Paul Reid, Ph.D., President & Owner

F IRM NAME STREET ADDRESS

Maitland Labs of Central Florida 7972 Forest City Rd

C ITY. STATE. Z IP CODE. COUNTRY TYPE ESTABUSHMENT INSPECTED

Orlando, FL 3281 0- 2907 503B Outsourcing Facility

• The storage/handling instrnctions, specifically "Protect from light" and the storage conditions are
not consistent with the batch record (15 -30°C, 59-86°F)
• The inactive ingredients, specifically: Sodium Hydroxide and Hydrochloric Acid, which are
listed on the master batch record
• The complete name of the inactive ingredients: Sodium Citrate Dihydrate and Citric Acid
Anhydrous
• "fuactive ingredient" appears on the label twice

Example of your diug product label that do not contain this info1mation:
• Nalbuphine HCl 10 mg/mL in 0.2% Saline

*DATES OF INSPECTION
2/19/2020(Wed), 2/20/2020(Thu), 2/21/2020(Fri), 2/25/2020(Tue), 2/28/2020(Fri)

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE Jessica L Pressley, Investigator 2/28/2020

OF THIS PAGE

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 5 of 5 PAGES