DEPARTMENT OF HEAL TH ANO HUMAN SERVICES 

FOOD ANO DRUG ADMINISTRATION 

DISTRICT OFFICE ADDRESS AND PHONE NUMBER 

8050 Marshall Drive, Suite 205 

Lenexa, KS 66214 

(913)495-5100 Fax:(913)495-5115 

Tndustry Information: www.fda.gov/oc/industry 

DA TE{S) OF INSPECTION 

3/7 /2023-4/5/2023 

FEI NUMBER 

3013927023 

NAME AND TITLE OF INDIVIDUAL TO IM-iOM REPORT IS ISSUED 

TO: Jarred D. Dudding, QA Director and Pha1macist-in-Charge 

FIRM NAME 

Apollo Care, LLC 

STREET ADDRESS 

3801 Mojave Ct Ste IOI 

CITY, STATE AND ZIP CODE 

Columbia, MO 65202-4042 

TYPE OF ESTABLISHMENT INSPECTED 

Outsourcing Facility 

THIS DOCUMENT LISTS OBSERVATIONS MADE BY THE FDA REPRESENTATIVE(S) DURING THE INSPECTION OF YOUR FACILITY. THEY ARE INSPECTIONAL 

OBSERVATIONS; AND DO NOT REPRESENT A FINAL AGENCY DETERMINATION REGARDING YOUR COMPLIANCE. IF YOU HAVE AN OBJECTION REGARDING AN 

OBSERVATION, OR HAVE IMPLEMENTED, OR PLAN TO IMPLEMENT CORRECTIVE ACTION IN RESPONSE TO AN OBSERVATION, YOU MAY DISCUSS THE 

OBJECTION OR ACTION VIIITH THE FDA REPRESENTATIVE(S) DURING THE INSPECTION OR SUBMIT THIS INFORMATION TO FDA AT THE ADDRESS ABOVE. IF 

YOU HAVE ANY QUESTIONS, PLEASE CONTACT FDA AT THE PHONE NUMBER ANO ADDRESS ABOVE. 

DURING AN INSPECTION OF YOUR FIRM (I) (WE) OBSERVED: 

OBSERVATION 1 

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 distributed. 

Specifically, 

A. An 8.000% leak (against a specification of[(b) (4) }) was found in your ISO 5 laminar airtlow 

hood, number:(5 ) (4) I, in :(5) (4) 1 lablj, during third party certification activities on 02/02/2023. You 

stated(b) ( 4) of the sterile drug products compounded by your firm are aseptically filled in this hood. You 

reviewed the certification report on 02/17/2023 and did not open a deviation or investigation to determine the 

potential impact on the approximately lbH•i batches of sterile drug products filled in this hood since the last time the 

HEPA filter passed an integrity test on 06/20/2022. In addition, you do not have any scientific rationale for the 

::! HEPA filter repair on the 8% leak. Furthermore, there is no documentation to support the lack of a full 

recertification of the hood after the patching occurred. 

Based on your beyond use dates (BUD), approximatelylbH•i batches of these sterile drug products were still within 

expiry as of03/20/2023. The sterile drug products potentially impacted by this HEPA filter leak include, but are 

not limited to, the following: 

-Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCI 250mg (0.1 %) added to 250mL IV bag 0.9% Sodium 

Chloride Injection (For Epidural Use Only), batch number:(5 ) (4 ) I 

-Fentanyl 50mcg/mL (2,500mcg Total Dose) 50mL Syringe (Injection for Intravenous Use Only), batch number 

(5)(4) J 

-Vancomycin 1.5g added to 500mL of0.9% Sodium Chloride (Injection for Intravenous Use Only), 

batch number [(of(4 ) I 

THIS IS A REPEAT OBSERVATION FROM THE 2018 INSPECTION 

r:./a-/41 

EMPLOYEE(S) Sl~~TURE EMPLOYEE(S) 

SEE 

REVERSE -- C/l R 

NAfiE AND TITLE (Print or T&: DATE ISSUED 

1.. fl II ..Ff:"' '4 .v -; SCS 0 '7 / S/ .;J.O>) 

OF THIS 

PAGE Conn.er rJ, 1\1\os)n , C&:> 

Wt1yl\e D. Mt &rar~, C.fO 

FORM FDA 483 (9/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS Page 1 of7 
DEPARTMENT OF HEAL TH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISTRICT OFFICE ADDRESS AND PHONE NUMBER DATE{S) OF INSPECTION 

8050 Marshall Drive, Suite 205 3/7 /2023-4/5/2023 

Lenexa, KS 66214 

(913)495-5100 Fax:(913)495-5115 FEI NUMBER 

3013927023 Industry Infonnation: www .fda.gov/oc/industry 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED 

TO: Jarred D. Dudding, QA Director and Pharmacist-in-Charge 

FIRM NAME STREET ADDRESS 

Apollo Care, LLC 3801 Mojave Ct Ste 101 

CITY, STATE ANO ZIP CODE TYPE OF ESTABLISHMENT INSPECTED 

Columbia, MO 65202-4042 Outsourcing Facility 

B. The following discrepancies were identified during review of your open investigation, number IR-23-002, in 

response to finding suspect microbial growth on approximately E5Jabels of Fentanyl 500mcg (2mcg/mL) and 

Ropivacaine HCI 250mg (O. l %) added to 250mL lV bag 0.9% Sodium Chloride Injection (For Epidural Use 

Only), batch number:(b) (4 ) I, on 01/24/2023: 

-You did not perform identification testing on the suspect microbial growth. 

-You did not perform any enhanced or expanded environmental monitoring in classified or unclassified areas as a 

result of the suspect microbial growth findings. 

-You removed the outer ~b) (4) bags from the Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCI 250mg 

(0.1 %) added to 250mL IV bag 0.9% Sodium Chloride Injection (For Epidural Use Only) without stability data or 

an adequate impact assessment to determine the impact on your beyond use dates for this product. Approximately 

~ nits of this product from batchj(D) (4) J were observed without oute~(D) (4) J bags in tbej(D) (4) I 

___J storage room on 03/07/2023. 

-You assumed this was the same microbial contamination as a previous event in July 20?2 with no scientific 

evidence. 

C. The following discrepancies were identified during review of your closed investigation, number IR-22-004, in 

response to finding suspect microbial growth on one label on Norepinephrine 8 mg added to 250 mL IV bag of 5% 

Dextrose Injection, batch number[(o) (4) l on 07/01/2022: 

-The JV bag with the suspect microbial growth was wiped down and relabeled for distribution. 

-The investigation states the suspect microbial growth was identified as Trichoderma harzianum and states this 

organism is unlikely to cause illness or harmful health implications in humans. 

-The investigation states future drug products held at room temperature would not be placed in bags but does not 

assess the impact on the light sensitive drug products. 

EMPLOYEE(S) SIGNATURE EMPLOYEE($) NAME AND TITLE (Print or Ty~ DATE ISSUED 

Sff ~#~JI£ C/4,f L, ,4 H~P.rtilNJJr / ~ cso 

REVERSE 

OF THIS ~~ c1n~r Con (\$LY t0 • lv\o..nr._ l G'&) PAGE 

'WUIN. W 0,y,, e D. Mc C.,raT~ t So 

FORM FDA 483 (9/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS Page 2 of 7 
DEPARTMENT OF HEAL TH ANO HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISTRICT OFFICE ADDRESS AND PHONE NUMBER DA TE(S) OF INSPECTION 

8050 Marshall Drive, Suite 205 3/7/2023-4/5/2023 

Lenexa, KS 66214 

(913)495-5100 Fax:(913)495-5115 FEI NUMBER 

3013927023 Industry Information: www.fda.gov/oc/industry 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED 

TO: Jarred D. Dudding, QA Director and Pharmacist-in-Charge 

FIRM NAME STREET ADDRESS 

Apollo Care, LLC 3801 Mojave Ct Ste 101 

CITY, STA TE AND ZIP CODE TYPE OF ESTABLISHMENT INSPECTED 

Columbia, MO 65202-4042 Outsourcing Facility 

D. The following discrepancies were identified during review of your closed deviation investigation, number 

D-22-067, into contaminated media plates, lot number Kb) (4) , received from your media plate supplier, which 

you initiated on 09/06/2022 and listed the duration of the event as 08/ 15/2022 to 09/ 15/2022: 

-Deviation report number D-22-067 states "There has been a noticeable increase in growth on samples taken. Any 

alert and/or action limits exceeded will be disregarded for the stated lots." The deviation report later states "All 

affected lots will be released pending product testing results." The deviation report lists ~batches of drug 

products that were affected, including, but not limited to, batch number[{b) (4) I (Vancomycin l.5 mg added to 

500 mL IV bag of0.9% Sodium Chloride for injection), batch number[(Df(4) J (Fentanyl 50 mcg/mL in 50 mL 

IV bag for injection), and batch number[(I:>) (4) I (Fentanyl 2 mcg/mL and Ropivacaine HCl 250 mg added to 

250 mL IV bag of 0.9% Sodium Chloride for epidural). 

-CAPA report number 22-033 states "EM to continue with suspect plates, however no interpretation of growth to 

be completed." 

-There was no formal investigation into the contaminated plates or the potential impact on sterile drug products 

compounded during this time. 

-The contaminated plates were still used and brought into ISO 8 and ISO 7 classified spaces. 

-The batch records affected by deviation D-22-067 list "N/ A" on the environmental monitoring sections with no 

further explanation of whether or not microbial growths were obtained. 

OBSERVATION 2 

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not 

include adequate validation of the aseptic process. 

Specifically, 

REVERSE ~1r.P: 

EMPLO~~~~ SIGNATURE NAME AND TITLE Sf'rint 

CAA.'-

EMPLOYEE($) 

4 11.,.p;-.... ,,,vJlL or Type) / DATE ISSUED 

SEE 'SCJ;O '1/S/::U~3 

OF THIS ~~ UYJn..e.r rJ. Mflnn I PAGE (@ 

At,!~ c.fflc, Wt>. Yn e. D. Mc ( ,raTh ~ C S 0 

FORM FDA 483 (9/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS Page3 of7 
DEPARTMENT OF HEAL TH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISTRICT OFFICE ADDRESS AND PHONE NUMBER DATE($) OF INSPECTION 

8050 Marshall Drive, Suite 205 3/7/2023-4/5/2023 

Lenexa, KS 66214 

(913)495-5100 Fax:(913)495-5115 FEI NUMBER 

3013927023 industry lnfonnation: www.fda.gov/oc/industry 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED 

TO: Jarred D. Dudding, QA Director and Pharmacist-in-Charge 

FIRM NAME STREET ADDRESS 

Apollo Care, LLC 3801 Mojave Ct Ste 101 

CITY, STATE AND ZIP CODE TYPE OF ESTABLISHMENT INSPECTED 

Columbia, MO 65202-4042 Outsourcing Facility 

A. As of 03/20/2023, your firm has never performed a media fill using 10 mL syringes. In December 2022, your 

firm began commercially compounding Ketamine 50 mg per 5 mL (10 mg/mL) in IO mL syringes and you began 

distributing them in January 2023. In addition, your recent media fill, conducted on 09/06/2022, was only 

performed using 30 mL syringes. As of 03/20/2023, you stated your firm only distributes IO m L and 50 mL 

syringes and you do not commercially compound any drug products in 30 mL syringes. 

B. The following discrepancies were identified during review of your visual inspection qualification program: 

-Your employees have never been qualified on visually inspecting syringes. Your firm compounds multiple sterile 

drug products in syringes, including, but not limited to, Fentanyl SO mcg/mL in 50 mL syringes for injection and 

Ketamine 50 mg per S mL in l O mL syringes for injection. 

-Your employees have never been quali tied on visuaJly inspecting and identifying critical defects in IV bags. Your

QA Director, JOO, stated the visual inspection qualificatior{Cb) <

4>] do not contain critical defects in IV bags, but 

instead use (b) (4)with critical defects. Your firm does not compound drug products in(b) (4)] In addition, your 

visual inspection qualification reports do not list defect categories such as minor, major, and critical. 

OBSERVATION 3 

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not 

followed. 

=

SpecificaJly

On 03/10/2023, 

ISO 

· 

, 

we observed an employee move atb) (4): beaker of non-sterile Vancomycin bulk solution from the 

7[(of(4 room into the ISO 5 hood without first wiping down the bottom of the beaker with Kb) (4) 

Your SOP number PRC00l. l, Cleanroom Activity and Aseptic Technique, requires supplies to be disinfected 

when placed into the direct compounding area in the ISO 5 hood. 

SEE ell~~ EMPLOYEE($) A NAME AND TITLE (Print or Typ_e) DATE ISSUED 

)/..t:F--IJ...,, /lX , ~c:.s 0 

REVERSE ~ / 5/ ..:ao;z3 

OF THIS (o r'I f\.V" rJ. Mo..nn, C PAGE 80 

I/V"-YriP O. Mc &ra.T~ ( so 

FORM FDA 483 (9/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS Page4of6 
DEPARTMENT OF HEAL TH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISTRICT OFFICE ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION 

8050 Marshall Drive, Suite 205 3/7/2023-4/5/2023 

Lenexa, KS 66214 

(913)495-5 l 00 Fax:(913)495-51 I 5 FEI NUMBER 

3013927023 Industry Information: www .fda.gov/oc/industry 

NAME ANO TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED 

TO: Jarred D. Dudding, QA Director and Pharmacist-in-Charge 

FIRM NAME STREET ADDRESS 

Apollo Care, LLC 3801 Mojave Ct Ste 101 

CITY, STATE ANO ZIP CODE TYPE OF ESTABLISHMENT INSPECTED 

Columbia, MO 65202-4042 Outsourcing Facility 

OBSERVATION 4 

Drug products are not stored under appropriate conditions of light so that their identity, strength, quality, and 

purity are not affected. 

Specifically, 

The following drug products are not stored in a manner to protect them from light: 

-Norepinephrine 4mg added to 250m.L of 5% Dextrose (Injection for Intravenous Use Only) - Lot[(~)_(4) __J 

-Norepinephrine 8mg added to 250mL of 5% Dextrose (Injection for Intravenous Use Only) - Lot[{ffi4 ) 7 -Norepinephrine 8mg added to 250mL 0.9% Sodium Chloride (Injection for Intravenous Use Only) - Lot 

(5) (4) J 

-Fentanyl 500 mcg & Ropivacaine HCI 250 mg added to 250 mL 0.9% Sodium Chloride - lot[(b) (4) _=i 

OBSERVATION 5 

The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(l0) 

(A). Specifically, the following information is not found on your drug product labels: 

A. The established name of the drug 

Examples of your drug product labels that do not contain this information: 

• Ketamine Injection 50 mg per 5 mL (10 mg/mL) Single-Use Syringe 

B. The storage and handling instruction 

Examples of drug product label where storage and handling instruction is not included: 

• Norepinephrine 4 mg added to 250 mL of 5% Dextrose 

• Norepinephrine 8 mg added to 250 mL of 5% Dextrose 

• Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride 

EMPLOY~~~SIGNATURE EMPLOYEE(S) NAME AND S 

SEE ~a'K~ Ct4,e. t- Ir ,+..,t: P '"A,.,, TITLE (Print or Tl'.P/!) DATE ISSUED 

JI& ,, !> G a 

REVERSE J.//5/~~3 

OF THIS 

PAGE ~~ Conrvu-- fv, Mo.Y'\n 1 C8D 

t\v"' ¢1"-v 11'1 er- tflayl\~ D, ,v\cur111T~ C5o 

FORM FDA 483 (9/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS Pages of6 
DEPARTMENT OF HEAL TH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISTRICT OFFICE ADDRESS AND PHONE NUMBER DATE(S) OF INSPECT/ON 

8050 Marshall Drive, Suite 205 3/7/2023-4/5/2023 

Lenexa, KS 66214 

(913)495-5100 Fax:(913)495-5115 FEI NUMBER 

3013927023 Industry Information: www.fda.gov/oc/industry 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED 

TO: Jarred D. Dudding, QA Director and Pharmacist-in-Charge 

FIRM NAME STREET ADDRESS 

Apollo Care, LLC 3801 Mojave Ct Ste IOI 

CITY, STATE AND ZIP CODE TYPE OF ESTABLISHMENT INSPECTED 

Columbia, MO 65202-4042 Outsourcing Facility 

OBSERVATION 6 

The container of your outsourcing facility's drug products is missing the container label and does not include 

information required by section 503B(a)(l 0)(B). 

Examples of drug products without containers labels: 

• Fentanyl 50 mcg/mL (2,500 mcg Total) in 50 mL Syringe 

• Ketamine lnjection 50 mg per 5 mL (10 mg/rnL), Single-Use Syringe 

• Phenylephrine HCI Injection 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe 

• Succinylcholine Cl Injection 100 mg per 5 mL (20 mg/mL), Single-Use Syringe 

• Vancomycin in various strengths added to 0.9% Sodium Chloride, IV bag 

• Midazolam lmg/mL (I 00mg) 1 0OmL IV Bag 

• Norepinephrine 4 mg added to 250 mL of 5% Dextrose 

• Norepinephrine 8 mg added to 250 mL of 5% Dextrose 

• Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride 

• Fentanyl 500 mcg (2 mcg/mL) and Ropivacaine HCl 250 mg added to 250 mL 0.9% Sodium Chloride Injection 

JV bag 

SEE 

REVERSE 

OFTH/S 

PAGE 

EMPLOYEE($) SIGNATURE 

~g~(7T 

~~r 

EMPLOYEE($) NAME AND TITLE (Print or Type) 

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CoY\ l'\l,r tJ • tv\.clnV\ I Cro 

W'«'f/\e t7, N'id,rQTJ,., C 50 

DATE 

o// 

ISSUED 

5/ ,.1Q .;,...J 

FORM FDA 483 (9/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS Page6 of6 
The observations of objectionable conditions and practices listed on the front of this form 

are reported: 

1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or 

2. To assist firms inspected in complying with the Acts and regulations enforced by the 

Food and Drug Administration . 

Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)) provides: 

"Upon completion of any such inspection of a factory, warehouse, consulting 

laboratory, or other establishment, and prior to leaving the premises, the officer or employee 

making the inspection shall give to the owner, operator, or agent in charge a report in 

writing setting forth any conditions or practices observed by him which, in his judgement, 

indicate that any food, drug, device, or cosmetic in such establishment (1) consists in whole 

or in part of any filthy, putrid, or decomposed substance, or (2) has been prepared, packed, 

or held under insanitary conditions whereby it may have become contaminated with filth, or 

whereby it may have been rendered injurious to health. A copy of such report shall be sent 

promptly to the Secretary." 

FORM FDA 483 (9/08)