DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISTRICT ADDRESS AND PHONE NUMBER 

555 Winderley Place, Suite 200 

Maitland, FL 32751 

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

ORAPHARM2_RESPONSES@fda.hhs.gov 

DATE(S) OF INSPECTION 

5/23/2023-6/2/2023* 

FEI NUMBER 

3013023419 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 

Kenneth G. Josefczyk, Director Centralized Pharmacy BayCare 

FIRM NAME 

BayCare Integrated Service Center, LLC 

/dba BayCare Central Pharmacy 

STREET ADDRESS 

7802 E Telecom Pkwy 

CITY, STATE, ZIP CODE, COUNTRY 

Temple Terrace, FL 33637-0928 

TYPE ESTABLISHMENT INSPECTED 

Outsourcing (503B) 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 with 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 and address above. 

DURING AN INSPECTION OF YOUR FIRM I OBSERVED: 

OBSERVATION 1 

The labels of your outsourcing facility's drug products do not include information required by section 

503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 

Specifically, the following information is not found on your drug product labels: 

a) Dosage form 

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

· Norepinephrine bitartrate 16 mg/250 mL 

· Oxytocin 30 units in 500 mL NaCl 0.9% 

· Ephedrine sulfate 25 mg/5 mL 

· Neostigmine methylsulfate 4 mg/4 mL 

· Succinylcholine chloride 100 mg/ 5 mL 

· Iohexol 2.4 g Iodine/8 mL 

b) A list of active and inactive ingredients, identified by established name and the quantity or 

proportion of each ingredient, as required under section 503B(a)(10)(A)(iii)(X). 

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

 · Norepinephrine bitartrate 16 mg/250 mL 

EMPLOYEE(S) SIGNATURE DATE ISSUED 

SEE REVERSE Joanne E King, Investigator 6/2/2023 

OF THIS PAGE Joanne E King

Investigator

Signed By: 1300174867

Date Signed: 06-02-2023 

X 13:33:08 

PAGE 1 of 2 PAGES FORM FDA 483 (09/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS 
Joanne E King

Investigator

Signed By: 1300174867

Date Signed: 06-02-2023 

X 13:33:08 

VATIONS 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISTRICT ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION 

555 Winderley Place, Suite 200 5/23/2023-6/2/2023* 

Maitland, FL 32751 FEI NUMBER 

3013023419 (407)475-4700 Fax:(407)475-4768 

ORAPHARM2_RESPONSES@fda.hhs.gov 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 

Kenneth G. Josefczyk, Director Centralized Pharmacy BayCare 

FIRM NAME STREET ADDRESS 

BayCare Integrated Service Center, LLC 7802 E Telecom Pkwy 

/dba BayCare Central Pharmacy 

CITY, STATE, ZIP CODE, COUNTRY TYPE ESTABLISHMENT INSPECTED 

Temple Terrace, FL 33637-0928 Outsourcing (503B) Facility 

*DATES OF INSPECTION 

5/23/2023(Tue), 5/24/2023(Wed), 5/25/2023(Thu), 5/26/2023(Fri), 5/31/2023(Wed), 6/01/2023(Thu), 

6/02/2023(Fri) 

SEE REVERSE

OF THIS PAGE

EMPLOYEE(S) SIGNATURE 

Joanne E King, Investigator 

DATE ISSUED 

6/2/2023 

PAGE 2 of 2 PAGES FORM FDA 483 (09/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSER
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."