Key facts
| Firm | SCA Pharmaceuticals LLC |
|---|---|
| FEI / inspection ID | 3013736415 |
| Inspection end date | December 20, 2024 |
| Citation count | 4 |
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 — 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. Specifically, A. Your fnm fail ed to adequately assess and implement an effective co 1Tective and preventative action plan to rem ediate numerous findings of fo reign material described as, cardboard, hair, fiber, or other, insi de the[( b ) (4) Itray packs con ta ining un- fi ll ed sterile syringes. These ~ ringe tray packs are received from l( b ) (4) Isyringe suppliers in configurations of D, <4 , an d □ units. Since November 2023, your fnm documented over 1200 supplier concern repo1is of fo reign material fo und in these syringe tray packs and continued to use them as container closures in your manufacturing activities. Your fnm continues to provi de~~ supplier complaints to syringe suppliers regarding the fo reign materials fo und in sten le synnge t ra ys. Foreign material was repo1ied in.
Observation 2 — Your fnm failed to establish written procedures fo r production and process
Your fnm failed to establish written procedures fo r production and process controls designed to assure that the drng products have the identity, strength, purity, and quality that they are pmported or re presented to possess. Specifically, Your fnm failed to adequately vali da te the manufacturing process for your sterile injectable products across multiple product lines, e.g., Vancomycin, Potass ium Chloride, Norepinephrine, Potassium Phosphate, Phenylephrine, Diltiazem, and Oxytocin. From October 2023 until December 2024, your fnm initiated approximately 24 manufacturing investigations class ified as "Confnm ed fo r potency OOS" representing 34 lots of sterile drng products. Your fnm fails to address the root causes of ''variable potency results" when using commercially available s ta1ting materials in order to ens ure finish ed drng product produced are made consistently and remain within a state of contro l. Your fnm fail ed to demonstrate the manufacturing process is capable of producing products that consistently meet established specifi cations and deliver.
Observation 3 — Procedures designed to prevent microbiological contamination of mug products pmpo1ting to be
Procedures designed to prevent microbiological contamination of mug products pmpo1ting to be sterile are not estab li shed and fo ll owed. Speci fi ca lly, yo ur operators were observed utilizing sterile goggles that are not designed to prevent microbial contamination. The sterile goggles have holes on the top and bottom allowing fo r potential paiticulates from operator's skin to have egress. The sterile goggles are a pait of the sterile gowning used fo r operators in your cleamoom and when preparing steri le mu g product in your [(b) (4) I ISO-5 Laminar Air Flow Hood. For exampl e, on 07/ 16/2024, an excursion, EXC-2024-0173 , repo1t was initiated due to a recove1y of 1 CFU/plate (speci fi cation [(6) (4 ) I) identi fi ed as Staphylococcus epidermis and, separately, Staphylococcus warneri in the ISO-5 environment le ft , righ t, and cen te r viable surface samples taken during the p ro duction of Phenvleohrine HCl.
Observation 4 — Aseptic processing ai·eas are de fi cient regarding the system fo r
Aseptic processing ai·eas are de fi cient regarding the system fo r monitoring environmental conditions. Speci fi ca lly, Section 10.2.1.2 of SOP # LAB-007-W, Environmental and Personal Monitoring of Classified Areas, Revision: 37, states "A minimum of one (1) active viable air sample must be co ll ected(6 ) (4) I during compounding activities." Your film 's procedure is de fi cient in that you do not collect active viable air environmental monitoring samples that ai·e representa tive of the beginning, middle, and end manufacturing process. For example, during the~I:> ) (4J manufacturing process fo r steri le mug product Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL Bag, Lot[(b (4) I, Expiration 02/09/2025, only one (1) active viable air sample is co ll ected during production activities. The same EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Jazmine N Br own, Investigat o r OF THIS PAGE Samir C Gala, Investigator -· 1 2/20/2024 ..81;1rit4~Jo\ZMIME Oillll-8tine« -.
SCA Pharmaceuticals LLC’s FDA history
Argus HQ has recorded 2 total FDA actions tied to SCA Pharmaceuticals LLC: 0 warning letters, 0 recalls, 0 approval records, and 2 Form 483 inspection citations.
Frequently asked questions
- Has SCA Pharmaceuticals LLC had other FDA inspection citations?
- Yes. Argus HQ has recorded 2 total FDA actions tied to SCA Pharmaceuticals LLC, including 2 Form 483 inspection citations.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3013736415.
- 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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Related enforcement actions
Full FDA history for SCA Pharmaceuticals 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 (2024). SCA Pharmaceuticals LLC — FDA Form 483 Inspection, December 20, 2024 (4 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-sca-pharmaceuticals-llc-2024-12-20-3013736415
"SCA Pharmaceuticals LLC — FDA Form 483 Inspection, December 20, 2024 (4 Citations)." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/483/fda-483-sca-pharmaceuticals-llc-2024-12-20-3013736415.
Argus HQ Research. "SCA Pharmaceuticals LLC — FDA Form 483 Inspection, December 20, 2024 (4 Citations)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-sca-pharmaceuticals-llc-2024-12-20-3013736415.
@misc{argushq_argushq_ai_483_fda_483_sca_pharmaceuticals_llc_2024_12_20_3013736415_2024,
title = {SCA Pharmaceuticals LLC — FDA Form 483 Inspection, December 20, 2024 (4 Citations)},
author = {{Argus HQ Research}},
year = {2024},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-sca-pharmaceuticals-llc-2024-12-20-3013736415},
note = {Accessed: July 13, 2026}
}