Key facts
| Firm | BayCare Integrated Service Center LLC |
|---|---|
| FEI / inspection ID | 3013023419 |
| Inspection end date | March 12, 2026 |
| Citation count | 9 |
Citations explained
Observation 1 — Aseptic processing areas are de fi cient regarding the system fo r
Aseptic processing areas are de fi cient regarding the system fo r monitoring environmental conditions. Specifically, A. Your fom does not routinely conduct dynamic via ble air monitoring within the critical ISO 5 classified fi lling zone of the ~6J (41 machine cell area throughout filling operations as required by SOP P- 204.7 "Quality Management J Program fo 1: Environmental and Personnel Sampling". The procedures requires that fo r [{Q) (4) "if a (6 H4 l is used on one day, it will be monitored under dynainic activity". This lack of viable air monitoring during active manufacturing phases fails to provide real-time assurance of aseptic conditions in a critical processing environment. B. Your ISO 7 Buffer Room, ISO 8 Ante Room, and associated [( D) (4) I, which serve as essential [(6) (4) I fo r materials and personnel supporting ISO 5 aseptic operations, are sampled ~ 4)1 instead of (5 4 )( ) during production. Your procedure P-204.7, "Quality.
Observation 2 — Aseptic processing areas are de fi cient regarding the system fo r
Aseptic processing areas are de fi cient regarding the system fo r cleaning and disinfecting the room and equipment to produce aseptic condition s. Specifica lly, A. Your disinfecta nt efficacy study is inadequate because it fa ils to demonstrate sporicidal activity. Your fnm relies on (6) (4) with a (6) (4) contact time as i ts primaiy sporici da l agent fo r 4 (b) ( 1 ~(6) (4) only).(b) (4) and b 4 c eanmg activities, as specified in SOP P-305.7 "Cleaning and Disinfection of ISO Classified Con ti-o ll ed Environments and Rooms". However, the va li da tion EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE J o se R Lopez, Compliance Officer 3/ 1 2/2026 OF THIS PAGE
Observation 3 — Your fnm failed to establish adequate written procedures fo r production and
Your fnm failed to establish adequate written procedures fo r production and process conti·o ls designed to assure that the diu g products have the identity, strength, purity, and quality that they are pmpo1ted or represented to possess. EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Jo se R Lo pez, Complia n ce Officer 3 /1 2/ 20 26 OF THIS PAGE -· °""-"""' --- 8"d~Ji:1SieR.LCIOCZ ci.:.-81,1r1e¢ 1 -(1)-1l-3l26 X 7:3195'-
Observation 4 — EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Jo se R Lo pez
EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Jo se R Lo pez, Complia n ce Officer 3 /1 2/ 20 26 OF THIS PAGE FORM of9 FDA 483 (09 8)
Observation 5 — The responsibilities and procedures applicable to the quality control unit are not
The responsibilities and procedures applicable to the quality control unit are not in writing and fully fo llowed. Specifically, Your fnm 's Quality Unit lacks segregation of duties among personnel involved in quality control activities, thereby comproinising the independence and integrity of quality oversigh t. Specifically, your Quality Unit, comprised of a single quality manager and one technician, assumes multi fa rious roles that include: • Collection of environmental and personnel monitoring samples. • Reading and interpretation of environmental and personnel monitoring sample results. • Initiation and conduct of investigations into deviations, including out-o f- specifi cation (OOS) environmental monitoring results. • R eview of batch records fo r compliance. • Final release of finish ed dmg products fo r distribution. For example, fr om 11 /17/25 to 11 /25/ 25 , Quality & Testing Manager collected, incubated, and EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE J o se R Lopez, Compliance Officer 3/ 1 2/2026 OF THIS PAGE
Observation 6 — There is a failure to thoroughly review any unexplained discrepancy whether or
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been ah eady distributed. Specifica lly, Your fnm prematurely released a po1tio n of diug product batch SUCC1002025 111 4 fo r distribution prior to the initiation and completion of a thorough investigation into a detected microbial recove1y , thereby fa iling to assure that the dmg product meets its specifi cations fo r quality and purity before release. Specifi cally: • Environmental monitoring samples collected during the processing of lot SUCC10020 25 111 4 detected a microbial recove1y (s ingle CFU on a pha1macist's 4 r(bH l glove cuff) on 11 /24/25, as recorded during the fi nal stage of incubation. • On 11/25/25, your Quality & Testing Manager segregated the lot by loader and authori ze d a paitial release of batch SUCC10020251114. The unaffected po1t ion of the lot was deemed appropriate fo r release, and 4 lbl < Xsyringes fr.
Observation 7 — Procedures designed to prevent microbiological con tamination of diug products pmpo1ting to
Procedures designed to prevent microbiological con tamination of diug products pmpo1ting to be sterile are not established. Specifically, Your fnm 's visual inspection procedures fo r products repackaged into intravenous (IV) bags are deficient. Your visual inspection procedures request to perfo 1m a 100% visual inspection of IV bags after bags have been label ed. For example, Batch Production Records F- 67 1. ca fo r Oxytocin and F- 67 1. yb fo r Fen tanyl Ropivacaine Epidural, un de r the "Visual Inspection (light box)" section, state: "Observe each labelled bag in the light box fo r no less than [(b (4) ,J ... Check fo r product clarity and label fo r legibility." There is no assurance that the label, once applied to the IV bag, will not obstruct or impede the detection of paiticulates or other critical defects within the product.
Observation 8 — EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Jose R Lopez, Compliance Officer
EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Jose R Lopez, Compliance Officer 3/ 1 2/2026 OF THIS PAGE -· °""-"""' 8"d~Ji:1SieR.LCIOCZ ci.:.-81,1r1e¢(1)-1l-3l26 X --- 17:3195' --
Observation 9 — Written procedures are not established fo r evaluations conducted at least annually
Written procedures are not established fo r evaluations conducted at least annually to review records associated with a representa tive number of batches, whether approved or rejected. Specifically, Your fnm does not maintain written records fo r annual product reviews conducted fo r your aseptically produced dmg products, including but not limited to the fo llowing info 1mation: Tren ds , repo1is , or summaries of quality indicators, a summaiy of all media fills per fo1med since last inspection, environmental monitoring trend data (microbial and paiiicle counts), personnel monitoring trend data, evaluations of investigations and effectiveness of coITective actions, change management, EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE J o s e R Lo pez, Comp lianc e Off ic er 3/ 1 2/2026 OF THIS PAGE
What a Form 483 means
A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.
BayCare Integrated Service Center LLC’s FDA history
Argus HQ has recorded 1 total FDA action tied to BayCare Integrated Service Center LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- What is an FDA Form 483?
- A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.
- Does this Form 483 mean BayCare Integrated Service Center LLC violated the law?
- No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.
- What happens after a Form 483 is issued?
- The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
- Has BayCare Integrated Service Center LLC had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for BayCare Integrated Service Center LLC so far. Argus ingests new FDA records daily.
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Related enforcement actions
Full FDA history for BayCare Integrated Service Center LLCCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Form 483 Record: BayCare Integrated Service Center LLC, March 12, 2026 — 9 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-baycare-integrated-service-center-llc-2026-03-12-3013023419
"Form 483 Record: BayCare Integrated Service Center LLC, March 12, 2026 — 9 Citations." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-baycare-integrated-service-center-llc-2026-03-12-3013023419.
Argus HQ Research. "Form 483 Record: BayCare Integrated Service Center LLC, March 12, 2026 — 9 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-baycare-integrated-service-center-llc-2026-03-12-3013023419.
@misc{argushq_argushq_ai_483_fda_483_baycare_integrated_service_center_llc_2026_03_12_3013023419_2026,
title = {Form 483 Record: BayCare Integrated Service Center LLC, March 12, 2026 — 9 Citations},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-baycare-integrated-service-center-llc-2026-03-12-3013023419},
note = {Accessed: July 13, 2026}
}