Has Pharmaneek Inc had other FDA inspection citations?

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

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

FEI / inspection ID: 3014484244.

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.

April 8, 2026 FDA Form 483 for Pharmaneek Inc

Here's the summary: FDA inspected Pharmaneek Inc in Indiana and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2026-04-08. FDA records classify Pharmaneek Inc as a producer of non sterile drug products. 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.

Key facts

Firm	Pharmaneek Inc
FEI / inspection ID	3014484244
Inspection end date	April 8, 2026
Citation count	3

Citations explained

Observation 1 — Hazardous chugs were produced without providing adequate containment segregation, and/or cleaning of

Hazardous chugs were produced without providing adequate containment segregation, and/or cleaning of work smfaces, utensils, and/or personnel to prevent cross-contamination. Specifically, The cunent cleaning process is deficient for the following reasons and does not provide assmance that hazardous ch1.1g product residue and cleaning agent residue are adequately removed from reusable glassware and utensils used in production of both non-hazardous and hazardous chug products: • On 03/30 /2 026 following the production of non-sterile hazardous chug Hych·oxymea I 00 mg/mL Oral Suspension Lot HU10010330260 (Beyond Use Date (BUD): 04/ 29 /26), the reusable utensils (such as m01tar and pestle and 1n-aduated cylinders) and a disposable weigh boat, utilized for production, were cleaned with [(o) (.i:J) l liquid and a reusable [{6JT~; No deactivating agent is cunently employed to ensme the inactivation and removal of hazardous chug residue from product contact surfaces and utensils. • The reusable washed utensils such as m01tar and pestle and the disposable weigh boat, that were used.

Observation 2 — Yom fmn failed to confirm that the quality of water was suitable

Yom fmn failed to confirm that the quality of water was suitable for its intended use in the production of non-sterile diug products. Specifically, The £inn used [( b) (4] water for the production of non-sterile drug products, including but not limited to Hydroxyurea 100 mg/mL Oral Suspension, Lot HU10010330260 (Date Made: 03 /30 /2 6, BUD: 04/29/ 26 ), Hydroxyurea 100 mg/mL Oral Suspension, Lot HU10010327260 (Date Made: 03 / 27 / 26 , BUD: 04/26/26) and Hydroxyurea 100 mg/mL Oral Suspension, Lot HU10010319260 (Date Made: 03 /19/ 26 , BUD: 04/28/26 ). The fum had no data to demonstrate that the water used met the specifications for (15) (4 )1 Water USP. The formula worksheet for Hydi·oxyurea 100 mg/mL Oral Suspension includes (b} (4 )1 Water USP as an ingredient, but the fum used[(o) (4 } water.

Observation 3 — Your fac.ility is not maintained in a good state of repair, creating

Your fac.ility is not maintained in a good state of repair, creating insanitaiy conditions whereby drng products may be contaminated with filth. Specifically, On 03 /30/2026, a ceiling tile in the control room where Hydroxyurea 100 mg/mL Oral Suspension, Lot HU10010330260 (Date Made: 03 /30/26, BUD: 04/29/26) was produced, and subsequently dispensed to the patient, was ob served to be chipped, with pa.ii of the ceiling tile missing and opened to the plenum space, potentially exposing the room to enviromnental contaminants. *DATES OF INSPECTION 03 /30/2026 (Mon), 03 /31/2026 (Tue), 04 /01 /2026 (Wed) 04/ 02 /2026 (Thu), 04/03/2026 (Fri), 04/06/2026 (Mon), 04/ 07 /2026 (Tue), 04 / 08 /2026 (Wed) (8 Day s)

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.

Pharmaneek Inc’s FDA history

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

Frequently asked questions

Has Pharmaneek Inc had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Pharmaneek Inc so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3014484244.
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 Pharmaneek 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). April 8, 2026 FDA Form 483 for Pharmaneek Inc — 3 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-pharmaneek-inc-2026-04-08-3014484244

MLA

"April 8, 2026 FDA Form 483 for Pharmaneek Inc — 3 Citations." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-pharmaneek-inc-2026-04-08-3014484244.

Chicago

Argus HQ Research. "April 8, 2026 FDA Form 483 for Pharmaneek Inc — 3 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-pharmaneek-inc-2026-04-08-3014484244.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_pharmaneek_inc_2026_04_08_3014484244_2026,
  title = {April 8, 2026 FDA Form 483 for Pharmaneek Inc — 3 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-pharmaneek-inc-2026-04-08-3014484244},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗