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 Hikma Injectables USA 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.

What happens after a Form 483 is issued?

The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.

Has Hikma Injectables USA Inc. had other FDA inspection citations?

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

August 8, 2025 FDA Form 483 for Hikma Injectables USA Inc.

Key facts

Firm	Hikma Injectables USA Inc.
FEI / inspection ID	3022897129
Inspection end date	August 8, 2025
Citation count	3

The short version: FDA inspected Hikma Injectables USA Inc. in New Jersey and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2025-08-08. FDA records classify Hikma Injectables USA 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.

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 — Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals

Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. Specifically, On 07/29/2025, black discoloration was observed on the interior HEPA bracket of the Aseptic Processing Workstation ). Th was located within Room 121-B and was being utilized in the sterility testing of the following: Ketamine HCL lot# 252050004D, Diltiazem HCL lot# 251910016D and Rocuronium Bromide lot# 252050002D.

Observation 2 — Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, The firm's procedure for collecting active viable air within the ISO-5 laminar airflow hood is not 1111 representative of the full duration of sterile production process. The firm will only collec of air within approximately and th.tn111B production process within the laminar airflow hood lasts approximate! . For example, the aseptic process for Ketamine HCL 50mg per 5mL Lot# 25150009D was initiated at on 06/10/202 5. The aseptic process concluded at and the active viable air sample was only collected at 9:22am.

Observation 3 — -- 2 of 4 -- DEPARTMENT OF HEALTH Al"ID HUMAN SERVICES FOOD

-- 2 of 4 -- DEPARTMENT OF HEALTH Al"ID HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

Hikma Injectables USA Inc.’s FDA history

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

Frequently asked questions

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 Hikma Injectables USA 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.
What happens after a Form 483 is issued?: The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
Has Hikma Injectables USA Inc. had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Hikma Injectables USA Inc. so far. Argus ingests new FDA records daily.

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Full FDA history for Hikma Injectables USA 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 (2025). August 8, 2025 FDA Form 483 for Hikma Injectables USA Inc. — 3 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-hikma-injectables-usa-inc-2025-08-08-3022897129

MLA

"August 8, 2025 FDA Form 483 for Hikma Injectables USA Inc. — 3 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-hikma-injectables-usa-inc-2025-08-08-3022897129.

Chicago

Argus HQ Research. "August 8, 2025 FDA Form 483 for Hikma Injectables USA Inc. — 3 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-hikma-injectables-usa-inc-2025-08-08-3022897129.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_hikma_injectables_usa_inc_2025_08_08_3022897129_2025,
  title = {August 8, 2025 FDA Form 483 for Hikma Injectables USA Inc. — 3 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-hikma-injectables-usa-inc-2025-08-08-3022897129},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗