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.

Does this Form 483 mean Richie Pharmacal Company, 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.

Richie Pharmacal Company, Inc — FDA Form 483 Inspection, December 12, 2024 (1 Citations)

Key facts

Firm	Richie Pharmacal Company, Inc
FEI / inspection ID	1025513
Inspection end date	December 12, 2024
Citation count	1

Key takeaway: FDA inspected Richie Pharmacal Company, Inc in United States and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2024-12-12. FDA records classify Richie Pharmacal Company, Inc as a drug wholesale distributor. 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 — Your firm does not have adequate systems and processes to enable compliance

Your firm does not have adequate systems and processes to enable compliance with the verification requirements of section 582(c) of the Drug Supply Chain Security Act (DSCSA). Specificall y, A. Your firm's unsigned written_procedure SOP 7.19, "Suspect and Illegitimate Product ," created 7-19-17, is inadequate in that it fails to describe systems and processes (1) to terminate a notification of illegitimate product in consultation with FDA and the SOP includes an invalid hyperlink to FDA Form 3911 on FDA's website for FDA Form 3911 ; (2) to identify suspect product; (3) to conduct investigations of suspect product in coordination with trading partners, which must include verifying the product identifier at the package level; and (4) to notify FDA, when applicable, that suspect product is not illegitimate product. Your firm 's unsigned written procedure SOP 3.11 , "Receiving Instructions ," revised 3-11-24, incorrectly states that disposition of product will be authorized by the board of pharmacy and the FDA. The DSCSA.

Richie Pharmacal Company, Inc’s FDA history

Argus HQ has recorded 1 total FDA action tied to Richie Pharmacal Company, Inc: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

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.
Does this Form 483 mean Richie Pharmacal Company, 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.

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Full FDA history for Richie Pharmacal Company, Inc

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 (2024). Richie Pharmacal Company, Inc — FDA Form 483 Inspection, December 12, 2024 (1 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-richie-pharmacal-company-inc-2024-12-12-1025513

MLA

"Richie Pharmacal Company, Inc — FDA Form 483 Inspection, December 12, 2024 (1 Citations)." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/483/fda-483-richie-pharmacal-company-inc-2024-12-12-1025513.

Chicago

Argus HQ Research. "Richie Pharmacal Company, Inc — FDA Form 483 Inspection, December 12, 2024 (1 Citations)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-richie-pharmacal-company-inc-2024-12-12-1025513.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_richie_pharmacal_company_inc_2024_12_12_1025513_2024,
  title = {Richie Pharmacal Company, Inc — FDA Form 483 Inspection, December 12, 2024 (1 Citations)},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-richie-pharmacal-company-inc-2024-12-12-1025513},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗