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

FEI / inspection ID: 3020928491.

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 Form 483 — Annovex Pharma Inc (July 3, 2026)

Here's the summary: FDA inspected Annovex Pharma Inc in Virginia and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2026-07-03. FDA records classify Annovex Pharma 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. 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.

Key facts

Firm	Annovex Pharma Inc
FEI / inspection ID	3020928491
Inspection end date	July 3, 2026
Citation count	1

Citations explained

Observation 1 — Aseptic processing areas are deficient regarding systems for maintaining any equipment

Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions. Specifically, your firm failed to ensure that the laminar airflow hoods used for the production of sterile and non-sterile drug products were maintained in a state of adequate control. During the [(b) (4) cleanroom certification conducted on January 28, 2026, al]Cb) <4 I 1 laminar airflow hoods at your facility were found to be operating outside the acceptable airflow velocity range at the time of certification, as documented by the as-found FAIL designation in Certification Report #02647- 20260128RTO 1: (o} (4) Your firm did not initiate an investigation or quality related event in response to these fi ndings and did not conduct a product impact assessment for sterile and non-sterile drug products produced in these laminar airflow hoods since the previous !(15) (4) I certification in July 2025. feUe1.i,iiR~ AMENDMEN T 1 EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Chris t ina K Theodoro u , Inves t iga t or 6/ 1 8/2026 OF THIS PAGE O,,..,..Jt Th~ ~ STIKAIC. X = tt'f wd 0&-1...20ll FORM FDA 483 (09/08) PAGE l of3 PAGES PREVIOUS EDmON OB SOLim! INSPECTIONAL 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.

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.

Annovex Pharma Inc’s FDA history

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

Frequently asked questions

What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3020928491.
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 Annovex Pharma 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 (2026). FDA Form 483 — Annovex Pharma Inc (July 3, 2026) — 1 Citations. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/annovex-pharma-3020928491-2026-07-03

MLA

"FDA Form 483 — Annovex Pharma Inc (July 3, 2026) — 1 Citations." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/annovex-pharma-3020928491-2026-07-03.

Chicago

Argus HQ Research. "FDA Form 483 — Annovex Pharma Inc (July 3, 2026) — 1 Citations." Digital Empire Holdings LLC. Accessed July 29, 2026. https://argushq.ai/483/annovex-pharma-3020928491-2026-07-03.

BibTeX

@misc{argushq_argushq_ai_483_annovex_pharma_3020928491_2026_07_03_2026,
  title = {FDA Form 483 — Annovex Pharma Inc (July 3, 2026) — 1 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/annovex-pharma-3020928491-2026-07-03},
  note = {Accessed: July 29, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗