Does this Form 483 mean SCA Pharmaceuticals Inc 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.

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

FEI / inspection ID: 3010683157.

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.

Form 483 Record: SCA Pharmaceuticals Inc, October 30, 2025

Key facts

Firm	SCA Pharmaceuticals Inc
FEI / inspection ID	3010683157
Inspection end date	October 30, 2025
Citation count	3

In short: FDA inspected SCA Pharmaceuticals Inc in Arkansas and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2025-10-30. FDA records classify SCA Pharmaceuticals Inc 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.

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 — Procedures designed to prevent microbiological contamination of drug products purporting to be

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. Specifically, Your firm failed to establish adequate procedures to monitor personnel who directly interface with the sterile manufacturing environment, particularly during critical operations where personnel actions could impact product sterility. Video footage (AR0 125 1010251125035913_Beginning.mp4) from the aseptic filling of Lot 1125035913 demonstrates sterile technicians entering the ISO ij(4J LFH environment between timestamps 9:37-9:56 and performing multiple critical tasks including: Removing filled syringes from the IS 4 K LFH. Placing and removing the air sampling equipment. Despite direct contact with the critical aseptic environment, the sterile technician performing these operations was not sampled for recovery of viable microorganisms during or after these activities.

Observation 2 — EMPI.OYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Demar io L Wa ll s

EMPI.OYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Demar io L Wa ll s, Inves tig a to r DEMAR ~~" 1 0 /3 0 / 2025 OF THIS PAGE Q L. LWALLS•S ~ALLS i=_ ,...,,,,o.>0 X ~ ..."' FORM FDA 433 (09/ 08) PREMOUS E DmONOBSOLErrE INSPECTION AL OBSERVATIONS PAGE I of4 PA GE S

Observation 3 — Laboratory controls do not include the establishment of scientifically sound and appropriate

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that drug product containers conform to appropriate standards of identity, strength, quality and purity. Specifically, SOP-ILP- 001 -LR Product Inspection and Defect Classification defines critical defects as those that may cause serious adverse reactions, including those that compromise the sterility of the drug product. However, your firm's defect classification system contains the following inadequacies: A. Your firm classifies all particulates/materials in the drug solution as major defects without distinguishing between extrinsic and intrinsic particles during the visual inspection process, some of which may increase risk of serious adverse reactions. B. Your firm has inappropriately classified foreign material trapped between stopper ribs as a minor defect despite the potential for these particles to impact the drug solution and compromise sterility. During visual inspection of prefilled syringes, foreign (unusual) material, including cardboard, EMPI.OYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Demario L Walls , I nvestigator DEMAR~~".

Frequently asked questions

Does this Form 483 mean SCA Pharmaceuticals Inc 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.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3010683157.
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.

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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 (2025). Form 483 Record: SCA Pharmaceuticals Inc, October 30, 2025 — 3 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-sca-pharmaceuticals-inc-2025-10-30-3010683157

MLA

"Form 483 Record: SCA Pharmaceuticals Inc, October 30, 2025 — 3 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-sca-pharmaceuticals-inc-2025-10-30-3010683157.

Chicago

Argus HQ Research. "Form 483 Record: SCA Pharmaceuticals Inc, October 30, 2025 — 3 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-sca-pharmaceuticals-inc-2025-10-30-3010683157.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_sca_pharmaceuticals_inc_2025_10_30_3010683157_2025,
  title = {Form 483 Record: SCA Pharmaceuticals Inc, October 30, 2025 — 3 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-sca-pharmaceuticals-inc-2025-10-30-3010683157},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗