Has AnazaoHealth Corporation had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for AnazaoHealth Corporation so far. Argus ingests new FDA records daily.

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

FEI / inspection ID: 3011152407.

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.

FDA Form 483 — AnazaoHealth Corporation (August 8, 2025)

Key facts

Firm	AnazaoHealth Corporation
FEI / inspection ID	3011152407
Inspection end date	August 8, 2025
Citation count	3

In short: FDA inspected AnazaoHealth Corporation in Nevada and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2025-08-08. FDA records classify AnazaoHealth Corporation 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 diug products pmp o1ting to

Procedures designed to prevent microbiological contamination of diug products pmp o1ting to be sterile are not establish ed, written and fo llowed. Specifically, A. During aseptic operations, the inne1most sterile packaging layer of stoppers was routinely briefly exposed to the ISO 7 environment prior to transfer into the ISO 5 Laminar Airflow Hood (LAFH), without disinfection. For example, the camera footage shows that during the production of Ascorbic Aci d3 0mL (PF-Non-Com), Lot # 1021502, Manufactured Date:[(b) (4) I, the TT.tl outerl ayerso fth e stopper packaging were cut open by an operator in the ISO 7 buffer room, and the operator working at the ISO 5 LAFH then extended his gloved hands outsi de the hood to pull the inner layer directly from the ISO 7 area into the ISO 5 area, expos ing the inner layer to the ISO 7 enviro nmen t. Your fnm produced approximatelyl6H-4J sterile batches of vial products per~6J ~ - B. Your fnm.

Observation 2 — Complaint records are de fi cient in that they do not include

Complaint records are de fi cient in that they do not include the findings of the investigation and follow- up . Specifically, Your fnm' s complaint investigation procedures are inadequate as investigations consistently fail to include retain sample testing when quality-related adverse events are repo1ied . For example: A. A provi de r repo1ied multiple complaints potentially related to inse1i ion site infections, including ten de rness, pain, swelling, and/or inflammation after using Testosterone pellets at various dosages in 2025. Your fnm's investigation conclu de d that no de fi ciencies were identified fo r these complaints; however, no retain sample testing was perfo1med to evaluate potential sterility, bioburden, or other quality attributes that could contribute to infection reactions. B. A provider repo1ie d that three patients experienced bmning sensations following administra tion of Ascorbic Acid (Preserved) 500mg/mL, Lot 740667 in 2025. Your fnm 's investigation conclu de d that no de fi ciencies were i de ntified; however, retmned.

Observation 3 — Laborato1y records do not include complete data derived fr om all tests

Laborato1y records do not include complete data derived fr om all tests, examinations and assay necess a1y to assure compliance with established specifications and standar ds . EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Taich un Qin, I nves t iga t or 8/8/2025 OF THIS PAGE T.....,or, X =F~~=s ,_.:;J,...J PAGE 3 of 4 PAGES F ORM FDA ~83 (09/ 08) PREVIOUS EDmON OBSOLEJE INS PEC TIONAL OB SERVATIONS

AnazaoHealth Corporation’s FDA history

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

Frequently asked questions

Has AnazaoHealth Corporation had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for AnazaoHealth Corporation so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3011152407.
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.

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Full FDA history for AnazaoHealth Corporation

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). FDA Form 483 — AnazaoHealth Corporation (August 8, 2025) — 3 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-anazaohealth-corporation-2025-08-08-3011152407

MLA

"FDA Form 483 — AnazaoHealth Corporation (August 8, 2025) — 3 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-anazaohealth-corporation-2025-08-08-3011152407.

Chicago

Argus HQ Research. "FDA Form 483 — AnazaoHealth Corporation (August 8, 2025) — 3 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-anazaohealth-corporation-2025-08-08-3011152407.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_anazaohealth_corporation_2025_08_08_3011152407_2025,
  title = {FDA Form 483 — AnazaoHealth Corporation (August 8, 2025) — 3 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-anazaohealth-corporation-2025-08-08-3011152407},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗