Key facts
| Firm | RC Outsourcing LLC |
|---|---|
| FEI / inspection ID | 3011967886 |
| Inspection end date | August 28, 2025 |
| Citation count | 8 |
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.
Citations explained
Observation 1 — Investigations of a failure of a ba tch or any of its
Investigations of a failure of a ba tch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific fa ilure or discrepancy. Specifically, Lot # #20250428-488A81 of Avastin® (bevacizumab) re-packaged on April 28, 2025, failed sterility testing. Non-Conformance Report NCR-2 identified the potential root cause as a medical condition the technician who re-packaged the lot was experiencing and fa i led to report. Your investigation resulted in the rejection of this lot. You did not extend the investigation to other lots re-packaged by the same techn ician. From April 21 , 2025 to July 21 , 2025, the technician re-packaged approxima tely ID1<4 r1ots of Avastin® (bevacizumab), including the lot that fa iled sterility testing. In addition, your firm fa iled to implement appropriate corrective action in that once you were informed of the issue you.
Observation 2 — Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, your firm has not developed an environment al monitoring plan based upon sound scien tific methods to include appropriate sampling frequency and tim ing. Your firm has no EMPLOYEE(S) SI GNATURE DATE ISS U ED SEE REVERSE Ma r ga re t M Annes, cso 8/28/202 5 OF THIS PAGE t,1.-g(llll'I W/Wlff cso 8 t,lftl 8y;: M~ W.HftS4 Delr ~0&-»203 X 12: U:SS
Observation 3 — 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 already distributed. Specifically, from October 1, 2024 to present your firm personnel have had approximately 43 instances of microbial recovery on sleeves. These include four (4) instances where 3CFU were recovered and one (1) instance where 2CFU were recovered . All others were 1CFU. EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Margare t M Annes, cso 8/28/2025 OF THIS PAGE t,1.-g(llll'I W/Wlff cso 8t,lftl 8y;:M~ W.HftS4 X Delr~0&-»203 12:U:SS PAGE 3 of? PAGES
Observation 4 — Procedures designed to prevent microbiological cont am ination of drug products purporting
Procedures designed to prevent microbiological cont am ination of drug products purporting to be sterile are not established, written and followed. Specifically, tips and caps for dropper bottles are placed directly onto the surface of the LFH when fill ing Povidone-lodine (re-packaging Betadine). Work Instruction Wl -22 P rod uction Protocol for Re12ac kaging Betadine (12ovidone- iodine) 5% Oohthalmic Solution in Sterile Droooer Bottles, version I 3.0 effective 2025-02- 14, states under section 5.3 Production Tasks: "6. Open ~~ o) (4) of the dropper bottles. Remove 4 ~b> ' rj (o) (4) (6){4] from the package. Remove he ( b) (4 ) I T he batch record fo r the fill ing of Povidone-lodine (re-packaging Be t ad ine) also states under one of the Production Tasks to "Remove dropper bottles from the package and ~6) (4) .J [(o) (4) I and set them with the [(o) (4) -1to the 1 4 \DJ \ ~oflh e holders ". This is.
Observation 5 — Laboratory controls do not include the establishment of scientifically sound and appropriate
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Margare t M Annes, cso 8/28/2025 OF THIS PAGE t,1.-g(llll'I W/Wlff cso 8 t,lftl 8y;: M~ W.HftS4 Delr ~0&-»203 X 12: U:SS PAGE 4 of? PAGES
Observation 6 — Reports of analysis from component suppliers are accepted in lieu of testi
Reports of analysis from component suppliers are accepted in lieu of testi ng each component for conformity w ith all appropriate written specifications, without performing at least one specific identity test on each component and establishing the rel iability of the supplier's analyses throug h appropriate validation of the supplier's test results at appropriate intervals. Specifically, your firm is compound ing Lidocaine HCI 2% Solution injection , Lidocaine 23%- Tetracaine 7% ointment ( LT ), Lidocaine, USP 20 %-Tetracaine, USP 6%-Phenylephrine, HCI 2% ointment (LTP), and the Benzocaine 20%-Lidocaine 6%-Tetracaine 4% ointment (BLT) from bu lk drug substances. Your firm does not perform any testi ng , includ ing an identity test, on the incoming bulk drug substances or excipients used to make these product s.
Observation 7 — Routine calibration of automatic, mechanical and electronic equipment is not performed according
Routine calibration of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance. EMPLO YEE(S) SI GNATURE DATE ISS U ED SEE REVERSE Mar g are t M Ann e s , cso 8/28/202 5 OF THIS PAGE t,1.-g(llll'I W /Wlff cso 8 t,lftl 8y;: M~ W.HftS4 X Delr ~0&-»203 12: U:SS PAGE 5of ? PAGES
Observation 8 — Ba tch production and control records do not include complete information relating
Ba tch production and control records do not include complete information relating to the production and control of each batch . Specifically, your firm is not record ing all perti nen t information regard ing ra w materials, equipment and consumables used during the compounding of drug products. For example, a) Your firm does not record the lot number of the sterile disposable beakers used to make the Lidocaine 2% Injection. b) Your firm did not record in the batch record the lot number of t he 4 (bl < 1 used for lot #20240725-0C03FA of Lidocaine 2% Solution injection. *DATES OF INSPECTION EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Margare t M Annes, cso 8/28/2025 OF THIS PAGE t,1.-g(llll'I W/Wlff cso 8t,lftl 8y;: M~W.HftS4 Delr~0&-»203 X 12: U:SS FORM FDA PAGE 6 of? PAGES 483 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OB SERVATIO NS
RC Outsourcing LLC’s FDA history
Argus HQ has recorded 1 total FDA action tied to RC Outsourcing 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 RC Outsourcing 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 RC Outsourcing LLC had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for RC Outsourcing LLC so far. Argus ingests new FDA records daily.
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Related enforcement actions
Full FDA history for RC Outsourcing 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 (2025). RC Outsourcing LLC — FDA Form 483 Inspection, August 28, 2025 (8 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-rc-outsourcing-llc-2025-08-28-3011967886
"RC Outsourcing LLC — FDA Form 483 Inspection, August 28, 2025 (8 Citations)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-rc-outsourcing-llc-2025-08-28-3011967886.
Argus HQ Research. "RC Outsourcing LLC — FDA Form 483 Inspection, August 28, 2025 (8 Citations)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-rc-outsourcing-llc-2025-08-28-3011967886.
@misc{argushq_argushq_ai_483_fda_483_rc_outsourcing_llc_2025_08_28_3011967886_2025,
title = {RC Outsourcing LLC — FDA Form 483 Inspection, August 28, 2025 (8 Citations)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-rc-outsourcing-llc-2025-08-28-3011967886},
note = {Accessed: July 15, 2026}
}