DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMBER 

US Cust omhouse Rrn900 200 Chest nut St 

Philadelphia, PA 19106 

(215)597-4 390 Ext:4 200 Fax: (215)597- 0875 

ORAPHARM1_RESPONSES@fda . hhs . gov 

OATE(S) OF INSPECTION 

2/27/2023- 3/30/2023* FEJNUMBER 

3009590582 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 

Rachel C. Schwartz, Direct or of Pharmacy 

FIRM NAME 

Central Admixt ure Pharmacy Services, 

I nc . 

STREET ADDRESS 

6580 Snowdrift Rd St e 100 

CITY. STATE. ZIP CODE. COUITTRY 

Allent own, PA 18106- 9331 

TYPE ESTABUSHMENT INSPECTED 

Out sourcing 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 detemiination regarding your compliance. If you have an objection regarding an 

observation, or have in1plemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or 

action with the FDA representative{s) during the inspection or submit this infonnation to FDA at the address above. If you have any 

questions, please contact FDA at the phone number and address above. 

DURING AN INSPECTION OF YOUR FIRM I 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 aheady distributed. 

Specifically, your fnm's investigation into mold and spore-fo1ming micro-organisms identified from 

environmental monitoring (EM) samples collected in ISO 5 classified clean room areas used in the 

production of sterile dmg products are deficient: 

A.Investigation NQE-US58-221214-564 was opened 12/14/2022 and closed 03/27/2023 for all mold 

recoveries during the month of November 2022. In November 2022, your fnm had five EM 

excursions of 1 CFU/mL (specification: j6j('ijCFU) identified as Penicillium chrysogenuml 

Penicillium species recovered in four different ISO 5 laminar air flow (LAF) hoods. Your fnm 

released two out of :iJ < of the affected lots in which 1 CFU of Penicillir § Qhfflgenum was 

recovered in lbll-4J different ISO 5 EM surface samples of LAF hoods (6) (,4) : Potassium 

Phosphate 30mmol/500mL NS, Lot (6) 4) j, Exp: 16 Feb 2023 and del Nido fo1mula 

(Plasmalyte), Lot# [(b) (4) I, Exp: 16 Jan 2023. Both lots were produced and released into 

market. Additional recoveries of Penicillium species were recovered in a viable air EM sample 

of ISO 5 LAF hood:11>n•iin which Vancomycin 1.25gram/ 250ml Dextrose, Lot# [(6) (4) I, Exp: 

05/07/2023 was produced. This lot was also released for further distribution. Your fnm's 

investigation failed to dete1mine and implement the appropriate corrective actions. 

B.On 11/9/2022, lCFU/mL of Nigrospora species was identified on the right sleeve of an aseptic 

EMPLOYEE(S) SIGNATURE DATE ISSUED 

SEE REVERSE Jazmine N Brown , I nvest igat o r 

OF THIS PAG E Jaan~NSn:Nlt 

8~8)'~N.8ro,,,n4 

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PAGE I of6 PAGES FORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION 

US Cus t omho u s e Rrn900 200 Che s t n ut St 2/27 /2023- 3/30/2023* 

Phil ade lphia, PA 1 91 06 FEJNUMBER 

30095 905 82 (21 5 ) 5 9 7 -4 390 Ext:4 200 Fax: (21 5 ) 5 9 7 - 08 75 

ORAPHARM1_ RESPONSES@ fda.hhs .gov 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 

Rac he l C. Schwartz, Direc t o r o f Pharmac y 

FIRM NAME STREET ADDRESS 

Cen tral Admixture Pharma c y Servic e s , 6 5 80 Snowdrift Rd Ste 1 00 

I nc . CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABU SHMENT INSPECTED 

Alle n t own , PA 1 81 06 - 9331 Outsourc i ng Fac i l ity 

technician's personnel monitoring sample 15cification: O cfu) during the preparation of 

fuduction 8:1 High Potassium, Lotd{E' {4) , Exp: 24 Dec 2022 and Maintenance 4:1 Low K 

(20mEq), Lot#[b ) ( 4) I, Exp: 24 Dec 2022. Additionally, on 01/31/2023, 1 CFU/mL of 

Nigrospora species was recovered on the right finge1iip of an aseptic technician's personnel 

monitoring sample during the preparation of Oxytocin 30 units/ 500mL NS, Lot#[o) {2J) I 

Exp: 01 May 2023. Your fnm released all lots for fuiiher distribution without a thorough 

investigation. 

C.On 12/23/2022, your fnm identified lCFU/mL of Chaetomium globosum, a mold species, on the 

right finger tip of an aseptic technician's personnel monitoring sample (specification: (tiJC•cfu) 

during the preparation of Reperfusate NO K, Loti{.{b ) 4) I, Exp: 02/13/2023. Your fnm 

released this lot for fmiher distribution without a thorough investigation. 

D.On 02/01/2023, your fnm identified 1 CFU/mL of a gram-negative bacteria, Klebsiella oxytoca, 

on the touch screen of your compounding machine ~_pecification: ltiH•cfu) that is within your ISO 

5 LAF hood, where Maintenance 8:1 Low K , Lot#OCb ) (4) I Exp: 18 Mar 2023, was 

produced. Your fnm released this lot for fuii her distribution without a thorough investigation. 

OBSERVATION 2 

Written records of investigations into unexplained discrepancies and the failure of a batch or any of its 

components to meet specifications do not always include the conclusions and follow-up. 

Specifically, your fnm's environmental monitoring (EM) and personnel monitoring (PM) data shows 

recove1y of spore fo1ming microorganisms of 1 CFU/mL in your ISO 5 critical zone areas for 

approximately 100 instances since November 2022 to March 2023. Despite recovering a significant 

number of bacteria, yeast, mold, and other spore fo1ming organisms, your fnm failed to conduct 

EMPLOYEE(S) SIGNATURE DATE ISSUED 

SEE REVERSE Jazmi ne N Brown , I nve s tigato r 

· 

3 /30/2023 

OF THIS PAGE Jaan~NSn:Nlt 

8~8)'~ 

X 1- N.8ro,,,n 4 

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FORM FDA ~83 (09/08) INSPEC PAGE 2 of6 PAGES PREVIOUS EDmON OBSOLEJE TIONAL OBSERVATIONS 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION 

US Cust omhouse Rrn900 200 Chest nut St 2/27/2023- 3/30/2023* 

Philadelphia, PA 1 91 06 FEJNUMBER 

3009590582 (2 1 5)597-4 390 Ext: 4200 Fax : (2 1 5)597- 0875 

ORAPHARM1_ RESPONSES@fda . hhs . gov 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 

Rachel C. Schwart z, Direct or of Pharmacy 

FIRM NAME STREET ADDRESS 

Cent ral Admixt ure Pharmacy Services, 6580 Snowdrift Rd St e 1 00 

I nc . CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABUSHMENT INSPECTED 

Allent own, PA 1 81 06 - 9331 Out sourcing Facilit y 

investigations into the root causes or implement adeq11ate co11~ective and preventative actions to mitigate 

the risk of mold and spore forming bacteria thereafter. During this same time frame, your fom 

continued to manufacture and distribute sterile injectable diug products made in the same ISO 5 

locations with recove1y of micro-organisms. The following are some examples of the di11g product(s) 

batches produced on the same days mold fo1ming bacteria was recovered from their respective ISO 5 

areas: 

A.On 01/26/2023, l CFU, identified as Micrococcus lutecus, was recovered on the right sleeve 

(Specifica~onf {tf.!D. of an operator during the production of Norephinephrine 4mg/250mL 

D5W, Lot i 6) (4) l, Exp: 26 April 2023 

B.On 02/02/2023, l CFU, identified as Brevibacterium species, was recovered on the right 

fingertip (Specification'<"H•c ru) of an operator during the production of Modified St. Thomas 

Fo1mula Low K (70eQ) 1 000mL, Lot# b) ( 4) Exp: 19 Mar 2023 

C.On 02/14/2023, l CFU, identified as Bacillus licheniformis, was recovered from the surface of 

a repeater pump in LAF hoodi~~~{~pecification lb><'cFU) during the production of Heparin 

2,500 units/ 500mL NS, Lot#[(b )-{4)7, Exp: 25 April 2023 

D.On 02/15/2023, l CFU, id~

:

n

FU) tified as Stahylococcus homi_nis, was recovered on a surface 

sample (Specification: (I>)( in the ISO 5 LAF hood'!ti><•>during the sterility testing of diu g 

product lots produced. Three batches were also compounded in the ISO 5 LAF hood 

LJm02/15/2023 were tested and released for distribution: Oxytocin 20 units, Lot#[~1(b~)~(~4~)-I 

Exp: 16 May 202t O~ocin 30 units, Lot#[(6) (4) I, Exp: 16 May 2023; and, Oxytocin 

30 units, Lot#[(o) (4)_J, Exp: 16 May 2023. 

In each of the above instances these finished sterile injectable products were released for 

distribution. 

EMPLOYEE(S) SIGNATURE DATE ISSUED 

SEE REVERSE Jazmine N Brown, Invest igat or 3/30/2023 

OF THIS PAGE 

PAGE 3 of6 PAGES FORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION 

US Cus t omho u s e Rrn900 200 Che s t n u t St 2/27 /2023- 3/30/2023* 

Phil ade lphia, PA 1 91 06 FEJNUMBER 

30095 905 82 (21 5 ) 5 9 7 -4 390 Ext: 4 200 Fax : (21 5 ) 5 9 7 - 08 75 

ORAPHARM1_ RESPONSES@ fda . hhs . g ov 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 

Rac he l C. Schwart z, Direc t o r o f Pharmac y 

FIRM NAME STREET ADDRESS 

Cen t ral Admixt ure Pharma c y Servic e s , 6 5 80 Snowdrift Rd St e 1 00 

I nc . CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABU SHMENT INSPECTED 

Alle n t o wn , PA 1 81 06 - 9331 Ou t sourc i ng Fac i l i t y 

OBSERVATION 3 

Laborato1y controls do not include the establishment of scientifically sound and appropriate sampling 

plans and test procedures designed to assure that diug products confo1m to appropriate standards of 

identity, strength, quality and purity. 

Specifically, 

A.Accordin~ our fnm's procedure, TP- CAPS-4000040, Ste f liry(esting Using[(b) (4) (6) (2J ) , step 2.6.3A states to collect a 4 b) ( ) aliquot to test the sterility of 

your sterile di11g_products using an alternative sterility test method via the Ko) (4) I 

[(6) (4) ] Your fnm lacks supporting data or scientific 

rationale demonstrating that a reduced sample volume relative to the volume recommended in 

USP<71> is at least equivalent to the USP method, For example, for your fnm's di11g product, 

Oxytocin 30 units/ 500mL NS, Lo{(6 ) (4) j, Exp: 01 May 2023, only 4 b) ( ) was tested from 

each of the containers collected, which is only bll of your fill volume. Your fnm provided no 

data to support the adequacy of conducting sterility testing with sample size volumes that are less 

than those required by the USP <71> sterility testing method. Since microbial contamination 

may not be unifo1mly distributed throughout a diug product unit, reduced sample volumes could 

potentially cause false negative sterility test results and inappropriate release of finished sterile 

injectable products into the market. 

Your fnm uses the [(6) -(4) I sterility test method with a maximum sample size ofil> {4 to 

conduct sterility testing on all finished sterile injectable products produced and distributed and 

this observation impacts all lots of sterile diug product cmTently released and within expiiy . 

I 

B. Your fnm incubates sterility test samples of di11g products from[(6 ) (4) days. The 

incubation period perfo1med for the method suitability studies allowed samRles of bacteria to be 

incubated for[(6) (4) I days and samples of fungi to be incubated for [(6) ·c4) I days. 

Your fnm' s method suitability studies examined growth from days [(b) ( 4) I (in USP<71> 

an incubation period of 14 days is requii·ed). Your fnm does not have any scientific justification 

for[(6 ) (4) I the incubation period used for sterile diug products using this alternative sterility 

I 

EMPLOYEE(S) SIGNATURE DATE ISSUED 

SEE REVERSE Jazmi ne N Bro wn , I nve s t i g a t o r 

OF THIS PAGE Jaan~NSn:Nlt 

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3/30/2023 

10 -4106 

PAGE 4 of6 PAGES FORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION 

US Cust omhouse Rrn900 200 Chest nut St 2/27/2023- 3/30/2023* 

Philadelphia, PA 1 91 06 FEJNUMBER 

3009590582 (21 5)597-4 390 Ext: 4200 Fax : (21 5)597- 0875 

ORAPHARM1_ RESPONSES@fda . hhs . gov 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 

Rachel C. Schwart z, Direct or of Pharmacy 

FIRM NAME STREET ADDRESS 

Cent ral Admixt ure Pharmacy Services, 6580 Snowdrift Rd St e 1 00 

I nc . CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABUSHMENT INSPECTED 

Allent own, PA 1 81 06 - 9331 Out sourcing Facilit y 

method. This observation applies to sterility testing of all finished sterile diu g products that your 

fom produces. 

OBSERVATION 4 

Each batch of diu g product pmporting to be sterile is not laborato1y tested to dete1mine confo1mance to 

such requirements. 

Specifically, there is no scientific rationale or data to support the use of a reduced samole size ofl(6) (4~ 

used by your fom in the alternate sterility testing system, b)(4) , which has a 

maximum sample size capacity of P>) (4f For example, the film's sterihty test sample size 4for the total 

parenteral nutrition (TPN) product, Trophamine 2% / Dextrose 10% product filled to lbl( YmL, is fb'~] 

Kt>) ('4] of the product volume, which is tested for sterility using the (6) {4) I. However, USP 

<71> requires a minimum sample size of 10% of the total volume '(llmlmL for the TPN example). Your 

fom uses this [(b) ( 4) ,J sterility test method to conduct sterility testing on all finished sterile 

injectable products proaucea and distributed and this observation impacts all lots of sterile diug product 

cmTently released and within expi1y. 

THIS OBSERVATION WAS PREVIOUSLY CITED IN 2015 AND 2018. 

OBSERVATION 5 

Procedures designed to prevent objectionable Inicroorganisms in diug products not required to be sterile 

are not established and followed. 

Specifically, 

A. On 03/01/2023, during the production of Micro Del Nido, L.otd(o) (4)7, Exp: 16 Apr 

·7 2023, which 

was perfo1med in the ve1i ical Laminar Air Flow (LAF) hooct:.'.J a [( b) { 4) was used to 

fill approximately [(o) -(4) I syringes. During the production process, I observed an employee block the 

critical areas from receiving first pass air flow from the 0Cof[4 ~ ISO 5 LAF hood when connecting and 

EMPLOYEE(S) SIGNATURE DATE ISSUED 

SEE REVERSE Jazmine N Brown, I nvest igat or 

OF THIS PAGE 

X · l 1- 3/30/2023 Jaan~NSn:Nlt 

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5 FORM FDA ~83 (09/08) PAGE of6 PAGES PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS 
Jaan~NSn:Nlt 

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DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION 

US Cus t omho u s e Rrn900 200 Che s t n ut St 2/27 /2023- 3/30/2023* 

Phil ade lphia, PA 1 91 06 FEJNUMBER 

30095 905 82 (21 5 ) 5 9 7 -4 390 Ext:4 200 Fax: (21 5 ) 5 9 7 - 08 75 

ORAPHARM1_ RESPONSES@ fda.hhs .gov 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 

Rac he l C. Schwartz, Direc t o r o f Pharmac y 

FIRM NAME STREET ADDRESS 

Cen tral Admixture Pharma c y Servic e s , 6 5 80 Snowdrift Rd Ste 1 00 

I nc . CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABU SHMENT INSPECTED 

Alle n t o wn , PA 1 81 06 - 9331 Outsourc i ng Fac i l ity 

removing the syringes from the product (6) (4 ~~ The operator was also observed inve1iing the syringe 

filled with sterile Micro Del Nido, Lot# ~b) ( 4 ) , pointing the open end straight down which blocked 

first pass ISO 5 air to cap the filled syringe. 

B. On 02/28/2023, during the filling process of Sodium Phosphate Lot[(6) (4) I Exp: 29 May 2023, 

your quality control technician was observed perfonning a finger-tip PM samole on an IV technician 

immediately after the IV technician sprayed their gloved hands with sterile [(b) ( 4) I while producing 

diug product in the ISO 5 LAF hood. 

OBSERVATION 6 

Appropriate controls are not exercised over computers or related systems to assure that changes in 

master production and control records or other records are instituted only by authorized personnel. 

Specifically, on 03/01/2023, I observed that a quality control chemist was able to change the time, time 

zone and date and save these changes on the Ultra Perfo1mance Liquid Chromatograpf JUPLC) 

systems which is used to dete1mined potency. The time, time zone, and date for your fnm's )(<l UPLC 

systems can be changed by the user with no requirement of adininistrative privileges thereby allowing 

for the altering of real-time records and data collection. Controls are not established to prevent changes 

to the set the time, date, and time zone of the UPLC systems. 

*DATES OF INSPECTION 

2/27/2023(Mon), 2/28/2023(Tue), 3/0l/2023(Wed), 3/02/2023(Thu), 3/03/2023(Fri), 3/28/2023(Tue), 

3/29/2023(Wed), 3/30/2023(Thu) 

SEE REVERSE 

OF THIS PAGE 

EMPLOYEE(S) SIGNATURE 

Jazmi ne N Bro wn , I nve s tigato r 

DATE ISSUED 

3/30/2023 

FORM FDA ~83 (09/08) PAGE 6 of6 PAGES PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS 
 

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 

judgment, 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."