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BayCare Integrated Service Center LLC — FDA Facility Profile

FEI 3013023419

BayCare Integrated Service Center LLC is an FDA-inspected facility (FEI 3013023419) located in Temple Terrace, FL, US. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection: Jun 2, 2023: Voluntary Action Indicated (VAI)
Inspections on record: 2 (2 VAI)
Last OAI inspection: None on record
Warning letters: None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Form 483 and inspection documents: 4 in FDA's reading room
Recalls as the recalling firm: 3, latest Dec 1, 2022

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

Date	Result	What FDA cited
Jun 2, 2023	Voluntary Action Indicated (VAI)	Drug product labels, fails to include (FDCA 503B(a)(10)(A))
Dec 10, 2019	Voluntary Action Indicated (VAI)	Approve or reject procedures or specs (21 CFR 211.22(c)) Procedures not in writing, fully followed (21 CFR 211.22(d)) Environmental Monitoring System (21 CFR 211.42(c)(10)(iv)) Investigations of discrepancies, failures (21 CFR 211.192) and 1 more

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

Date	Class	Recall	Product and reason
Dec 1, 2022	Not yet classified	D-0086-2023	Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count… Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Feb 14, 2022	Not yet classified	D-0569-2022	Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only, BayCare… Subpotent drug
Jul 30, 2021	Not yet classified	D-0702-2021	Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only… Lack of sterility assurance

Form 483s and inspection documents

Mar 12, 2026: 483 on FDA.gov
Jun 2, 2023: 483 on FDA.gov
Sep 13, 2021: Untitled Letter on FDA.gov
Dec 10, 2019: 483 on FDA.gov

Facility details

Company: BayCare Integrated Service Center LLC
Location: Temple Terrace, FL (US)
Source: inspections