Has RC Outsourcing LLC had other FDA inspection citations?

Yes. Argus HQ has recorded 2 total FDA actions tied to RC Outsourcing LLC, including 2 Form 483 inspection citations.

What is the FEI / inspection ID for this Form 483?

FEI / inspection ID: 3011967886.

Is a Form 483 the same as a Warning Letter?

No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.

Where can I read the full Form 483?

The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.

RC Outsourcing LLC — FDA Form 483 Inspection, September 3, 2026 (8 Citations)

FDA inspected RC Outsourcing LLC in Ohio and issued a Form 483 listing 8 inspectional observations following an inspection that concluded 2026-09-03. FDA records classify RC Outsourcing LLC as a outsourcing facility. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record. 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.

Key facts

Firm	RC Outsourcing LLC
FEI / inspection ID	3011967886
Inspection end date	September 3, 2026
Citation count	8

Citations explained

Observation 1 — Procedures designed to prevent microbiological contamination of drug products purporting

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process. Specifically, A. Your firm conducted Airflow Visua li zation (AFV) studies (smoke studies) for ISO 5 Lami nar Flow Hood :t:l (LFH f.l and Laminar Flow Hood ~l (LFH ~l under both static and dynamic conditions in August 20 25 and February 2026. No fo rm al study reports or supporting doc umentation were available for review for either study. The record s lacked the fo llowing critical study elements: the type of smoke sources, the stated study purpose, targeted test locations, and personnel activities performed during dynamic conditions, real-time observations, and conclusions. Although video recordings of the AFV studies were captured, they were not accompanied by written protocols, contemporaneous docum entation, or summary reports sufficient to contextualize, interpret, or substantiate the visual finding s. B. Discrepancies were identified in the Airflow Visualization (AFV) records (videos) for ISO 5 Laminar Flow Hoo d:] (LF 'ttiH•> and Laminar Flow Hood :t:l (LFH :r,f) fr om studies completed in August

Observation 1 — D, operators exit and re-enter the ISO 7 cleanroom through the ISO 8 anteroom multiple

D, operators exit and re-enter the ISO 7 cleanroom through the ISO 8 anteroom multiple times during the filling/repackaging operation and place their head/face coverings and goggles into the ISO 5 critical area during the filling process. The absence of head/face cover and google sampling therefore leaves a significant gap in personnel contamination monitoring. II. Personnel sampling for fingertips and gown sleeves is performed only (6) @) , not after completing the first half. The firm's current sampling practice, therefore, does not adequately represent the full fingertip and gown s leeve contamination exposure throughout the filling/repackaging cycle. This practice does not adeq uately represent the fu ll fingertip and gown sleeve contamination exposure throughout the fillin g/repackaging cycle, as the first half of the lot is completed prior to the ISO 8 anteroom exit and is not captured b 15) (4) sampling. iii. Your firm does not perform surface sampling in the ISO 8 anteroom on a routine basis; 15 collected everyl"H•> as part of the ISO room qualification ...pr-o_gr_a~m--. Additionally, while your finn conducts lbH•i active air sampling, the selected sampling frequencies and

Observation 2 — There is a failure to thoroughly review any unexplained discrepancy and the failure of a

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, Sterility test failure investigations for aseptically re-packaged Avastin 1.25 mg/0.05 mL were inadequate and failed to identify probable root causes. Since October 2025, the firm has rejected four batches due to sterility EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Kara J Wr igh t, I nv e s t ig at o r 9/3/2026 OF THIS PAGE P ushp a S J a y a s ekara, I nv e s t ig at o r ~ r o..Ancn J ere my T Da u tr ich , I nv e s t ig at o r = J~EMY T. X ~~1t"' \ Oi-i)l-2026 of FORM FDA 483 (09/08) PAGE 6 12 PAGES PREVIOUS EDmON OB SOLim! INSPECTIONAL OBSERVATIONS -- 6 of 13 -- DEPART!\fi:NT OF HEALTH Al~ HUMAN SERVICES FOOD AND DRUG ADMINISTRATION D I STRI CT ADDRESS ANO PHONE N UMBER DATE(S) OF INSPECTION 550 Ma in S treet, S te 4 - 930 8 /24/2026 - 9/3/2026* Cincinn at i , OH 4 5202 FEINUMBER 3011967 88 6 (513)322 - 0 7 00 Fa x : (513)679 - 2772 NAME AN O TITLE OF IND IVIDUAL T O WHOM REPORT ISSUED Ra ymond Rob ert Car lson Own er FIRM NAME ' STREET A DDRESS RC Out sou

Observation 3 — Separate or defined areas to prevent contamination or mix-ups are deficient regarding the

Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations. Specifically, A. Personnel and material flow into and out of the ISO 7 and ISO 8 classified areas occurs through a single shared pathway that passes directly through the visual inspection and labeling room. Gowning, EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Kara J Wr igh t, I nv e s t ig at o r 9/3/2026 OF THIS PAGE P ushp a S J a y a s ekara, I nv e s t ig at o r ~ro..Ancn J ere my T Da u tr ich , I nv e s t ig at o r = J~EMY T. X ~~1t"' \ Oi-i)l-2026 of FORM FDA 483 (09/08) IN PAGE 7 12 P AGES PREVIOUS EDmON OB SOLim! SPECTIONAL OBSERVATIONS -- 7 of 13 -- DEPART!\fi:NT OF HEALTH Al~ HUM AN SERVICES FOOD AND DRUG ADMINISTRATION D ISTRI CT ADDRESS ANO PHONE N UM B ER DATE(S) OF I NSPECTI ON 55 0 Mai n St ree t , St e 4 - 930 8/2 4 /2026 - 9 /3/2026 * Ci nc i nn a t i, OH 4 5 202 FEINUMBER 301196 7 886 (5 1 3)322 - 0 7 00 Fax : ( 51 3)6 7 9- 2 77 2 NAME ANO TITLE OF IND IVIDUAL T O WH OM R EPORT ISSU ED Raymond Rob er t Car lson , Own er F IRM NAME STREET A DDRESS RC Ou t so u r c i ng , LLC 102 E Wa t e r St C ITY. STATE. ZIP CODE. COU NTRY TYPE EST

Observation 4 — EM PLOYEE(S) SIGNATURE DATE ISSUED SEE RE V ERSE Kara J Wri g h t , I n ve s t i g a t o

EM PLOYEE(S) SIGNATURE DATE ISSUED SEE RE V ERSE Kara J Wri g h t , I n ve s t i g a t o r 9/3/2026 OF THIS PAG E Pu s hp a S Jaya s ekara, I n ve s t i g a t o r Jeremy T Da u t ri c h, I n ve s t i g a t o r FORM FDA 483 ( 09/08) PREVIOUS EDmON OBSOLim! INSPECTIONAL OBSERVATIONS PAGE 8 of 12 PAGES -- 8 of 13 -- DEPART!\fi:NT OF HEALTH Al~ HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMBER DATE(S) OF I NSPECTI ON 55 0 Mai n St ree t , St e 4 - 930 8 /2 4 /2026 - 9/ 3 /2026 * Ci nc i nn a t i, OH 4 5 202 FEI NUMB ER 301196 7 88 6 (5 1 3)322 - 0 7 00 Fax : ( 51 3)6 7 9- 2 77 2 NAME ANO TITLE OF INDIVIDUAL TO WH OM REPORT ISSU ED Raymond Rob er t Car lson Own er FIRM NAME ' STREET A DDRESS RC Ou t so u r c i ng , LLC 1 02 E Wa t e r St CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABUSHME NT INS PECTED Lo we ll vi ll e, OH 444 36 - 111 7 Out s o u rci n g F aci l i t y There is a lack of written procedur es a ss ig nin g responsibility, providing cleaning schedules and de scribing in sufficie nt d etail the m eth od s, e quipm ent and mat erials to be us ed for s anitation . Specifically, A. Your firm's cleaning procedu re is inadequate. I. Your firm stated that o

Observation 6 — Laboratory controls do not include the establis hme nt of scientifically s ound and

Laboratory controls do not include the establis hme nt of scientifically s ound and appropriate s pe cifications d es i gned to assure t hat drug pr oducts co nform to appropri ate stand ards of identity, s trength, qua lity and purity. Specifically, Your firm continues to fail to provide a scientific rationale to support the established method a nd limits for subvisible particle testing of Avastin (bevacizumab) 1.75 mg/0.07 mL for intrav itreal injection. Your firm releas es this product using a subvisible particulate matter specification ofl(6) (4) ] partic le s/container at U μm and (b) (4 ) particles/container at 4 '(l>H 1 μm. Al (r.l lots associated with endophthalmitis ad verse events were rele as ed using this particulate matter specificati on. This observation is a repeat observation from the previous FDA 483, List of Observations, issued on 11/04/2024.

Observation 7 — EM PLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Kara J Wr igh t, I nv e s t ig at o r

EM PLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Kara J Wr igh t, I nv e s t ig at o r 9/3/2026 OF THIS PAGE P ushp a S J a y a s ekara, I nv e s t ig at o r ~ro..Ancn J ere my T Da u tr ich , I nv e s t ig at o r = J~EMY T. X ~~1t"'\ Oi-i)l-2026 FORM FDA 483 (09/08) PREVIOUS EDmON OB SOLim! INSPECTIONAL OBSERVATIONS PAGE 10 of 12 PAGES -- 10 of 13 -- DEPART!\fi:NT OF HEALTH Al~ HUMAN SERVICES FOOD AND DRUG ADMINISTRATION D ISTRI CT ADDRESS ANO PHONE N UMBER DATE(S) OF INSP ECTION 55 0 Mai n S treet, S te 4- 930 8 /2 4 /2026 - 9/ 3 /2026 * Ci nc i nn ati, OH 45 202 FEINUMBER 3 01196 7 88 6 (5 1 3)322 - 0 7 00 Fax : ( 51 3)6 7 9- 2 77 2 NAME ANO TITLE OF IND IVIDUAL T O WH OM REPORT ISSU ED Raymond Rob ert Car lson , Own er F IRM NAME STREET ADDRESS RC Ou t so u r c i ng , LLC 1 02 E Wa t er St C ITY. STATE. ZIP CODE. COUNTRY TYPE ESTABUSHME NT INSPECTED Lo we ll vi ll e, OH 444 36 - 111 7 Out s o u rci n g Faci l i t y Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices and written procedures required by current good manufacturing practice regulations. Specifically, A. Your firm does not conduct pe

Observation 8 — Drug product expiration dates are not related to the storage conditions stated on the

Drug product expiration dates are not related to the storage conditions stated on the labeling, as determined by stability studie s. Specifically, Your firm's product labels do not specify required storage temperature conditions, and the assigned rH•>7 beyond-use date (BUD) is not supported by stability testing. For example: your firm has failed to specify required storage temperature conditions on product labels, despite assigning a r ><•>7 beyond-use date (BUD). For example, your firm stated that stability testing is not conducted for its non-sterile compounded products on the basis that the water activity content is less than <"><•>%, with a <"H•>- • BUD assigned at a controlled room temperature o tfH•> I However, all three non-sterile product labels reviewed during the inspection indicated only "room temperature," without further qualification or specification EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Kara J Wri g ht, I n ve s ti g at o r 9/3/2026 OF THIS PAGE Pu s hp a S Jaya s ekara, I n ve s ti g at o r Jeremy T Da u tri c h, I n ve s ti g at o r FORM FDA 483 ( 09/08) PAGE 11 of 12 PAG ES PREVIOUS EDmON OBSOLim! INSPECTIONAL OBSERVATIONS -- 11 of 13 -- FORM FDA 483 (09/0

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.

RC Outsourcing LLC’s FDA history

Argus HQ has recorded 2 total FDA actions tied to RC Outsourcing LLC: 0 warning letters, 0 recalls, 0 approval records, and 2 Form 483 inspection citations.

Frequently asked questions

Has RC Outsourcing LLC had other FDA inspection citations?: Yes. Argus HQ has recorded 2 total FDA actions tied to RC Outsourcing LLC, including 2 Form 483 inspection citations.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3011967886.
Is a Form 483 the same as a Warning Letter?: No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.
Where can I read the full Form 483?: The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.

See if this 483 escalates to a warning letter — before your auditor asks.

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Full FDA history for RC Outsourcing LLC

Compiled 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.

APA

Argus HQ Research (2026). RC Outsourcing LLC — FDA Form 483 Inspection, September 3, 2026 (8 Citations). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/rc-outsourcing-3011967886-2026-09-03

MLA

"RC Outsourcing LLC — FDA Form 483 Inspection, September 3, 2026 (8 Citations)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/rc-outsourcing-3011967886-2026-09-03.

Chicago

Argus HQ Research. "RC Outsourcing LLC — FDA Form 483 Inspection, September 3, 2026 (8 Citations)." Digital Empire Holdings LLC. Accessed October 12, 2026. https://argushq.ai/483/rc-outsourcing-3011967886-2026-09-03.

BibTeX

@misc{argushq_argushq_ai_483_rc_outsourcing_3011967886_2026_09_03_2026,
  title = {RC Outsourcing LLC — FDA Form 483 Inspection, September 3, 2026 (8 Citations)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/rc-outsourcing-3011967886-2026-09-03},
  note = {Accessed: October 12, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗