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.

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.

FDA Inspects SCA Pharmaceuticals LLC: Form 483 with 2 Citations (March 13, 2026)

Key facts

Firm	SCA Pharmaceuticals LLC
FEI / inspection ID	3013736415
Inspection end date	March 13, 2026
Citation count	2

In short: FDA inspected SCA Pharmaceuticals LLC in Connecticut and issued a Form 483 listing 2 inspectional observations following an inspection that concluded 2026-03-13. FDA records classify SCA Pharmaceuticals 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.

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 and followed. Specifically, Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed. Specifically, A.Your firm has initiated approximately 46 Excursion (EXC), representing !tiH• batches of product, reports for microorganisms recovered from the ISO-5 critical zone in the Laminar Flow Hoods where sterile drug products are compounded. Since December 2024 organisms recovered included Staphylococcus species (epidermidis, hominis, capitis, haemolyticus), Bacillus simplex (clausii, infantis, circulans), Corynebacterium tuberculostearicum, Microcococcus luteus, and other organisms such as Kocuria, Peribacillus, Paenibacillus, Fictibacillus, Streptomyces, Cladosporium, Sphigmonas and Penicillium citrinum. These organisms have been characterized as either spore forming, or non-spore forming organisms recovered from either gloved fingertip, sleeve monitoring, active air, and/or passive air samples. Of the approximate 46 excursions initiated affecting multiple products batches including Phenyle

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

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, • Your firm failed to identify the root cause of particulate contamination in your drug products intended to be sterile and failed to implement effective corrective and preventive actions to prevent recurrence. These deviation investigations have been described as, Investigation Major Particulate Matter DRL Threshold Exceedance, 100% Visual Inspection Particulate Matter Threshold Exceedance, AQL Failure, and Major DRL Particulate Matter Threshold Exceedance. Since December 2024, your firm has initiated approximately 110 deviation investigations due to visual inspection failures for particulates. The majority of the deviation reports have been EMPI.OYEE( S) SIGNATURE OATE ISSUEO SEE REVERSE Simone E Pitts , Nat i o n a l E xper t , Dr u gs -·- 3/13/2026 OF THIS PAGE ,- 10n,11 E,oert. O,.O,, ~8y: $1MONE.

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.

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

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.
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.

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Full FDA history for SCA Pharmaceuticals 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). FDA Inspects SCA Pharmaceuticals LLC: Form 483 with 2 Citations (March 13, 2026). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-sca-pharmaceuticals-llc-2026-03-13-3013736415

MLA

"FDA Inspects SCA Pharmaceuticals LLC: Form 483 with 2 Citations (March 13, 2026)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-sca-pharmaceuticals-llc-2026-03-13-3013736415.

Chicago

Argus HQ Research. "FDA Inspects SCA Pharmaceuticals LLC: Form 483 with 2 Citations (March 13, 2026)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-sca-pharmaceuticals-llc-2026-03-13-3013736415.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_sca_pharmaceuticals_llc_2026_03_13_3013736415_2026,
  title = {FDA Inspects SCA Pharmaceuticals LLC: Form 483 with 2 Citations (March 13, 2026)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-sca-pharmaceuticals-llc-2026-03-13-3013736415},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗