Key facts
| Firm | Molecular PharmaGroup LLC |
|---|---|
| FEI / inspection ID | 3014413265 |
| Inspection end date | August 11, 2025 |
| Citation count | 3 |
Citations explained
Observation 1 — Aseptic processing areas are deficient regarding systems for maintaining any equipment used
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic condition s. Specifically, The fin~ 's ISO 5 ~ 1) ) Ve1~ica~ Laminar Air _Flow _(V-LAF) hood (Equipm~nt ID: MPG~065), located m ISO 7 Room tl 11 >, which 1s used fo r stenle fillmg of Ethanol 70% (v/v) mto 5 mL synnges, lacks a magnehelic gauge to measure the differential pressure between the ISO 5 LAF hood and ISO 7 room. There is no assurance that potential contaminants from the ISO 7 room do not enter the ISO 5 V - LAF during routine sterile filling operations. Batches of Ethanol 70% (v/v), including, but not limi te d to, batches# MFG-PC004(B)-021-25 (BUD: 24SEP2025), MFG-PC004(B)-0 23 - 25 (BUD: 13DEC2025), and MFG-PC004(B)-025-25 (BUD: 22DEC2025), have been filled in the ISO 5 V-LAF and released for distribution.
Observation 2 — Procedures designed to prevent microbiological contamination of drng products pmpo1ting to be
Procedures designed to prevent microbiological contamination of drng products pmpo1ting to be sterile are not established, written and followed. Specifically,
Observation 3 — Written procedures are not established for evaluations conducted at least annually to
Written procedures are not established for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected. Specifically, The fnm has not established a written procedure for conducting Annual Product Reviews (APRs). Additionally, the fnm failed to conduct Annual Product Reviews for approximately □ batches
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.
Molecular PharmaGroup LLC’s FDA history
Argus HQ has recorded 1 total FDA action tied to Molecular PharmaGroup LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Does this Form 483 mean Molecular PharmaGroup LLC 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 Molecular PharmaGroup LLC had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Molecular PharmaGroup LLC so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3014413265.
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Related enforcement actions
Full FDA history for Molecular PharmaGroup LLCCompiled 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.
Argus HQ Research (2025). FDA Inspects Molecular PharmaGroup LLC: Form 483 with 3 Citations (August 11, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-molecular-pharmagroup-llc-2025-08-11-3014413265
"FDA Inspects Molecular PharmaGroup LLC: Form 483 with 3 Citations (August 11, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-molecular-pharmagroup-llc-2025-08-11-3014413265.
Argus HQ Research. "FDA Inspects Molecular PharmaGroup LLC: Form 483 with 3 Citations (August 11, 2025)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-molecular-pharmagroup-llc-2025-08-11-3014413265.
@misc{argushq_argushq_ai_483_fda_483_molecular_pharmagroup_llc_2025_08_11_3014413265_2025,
title = {FDA Inspects Molecular PharmaGroup LLC: Form 483 with 3 Citations (August 11, 2025)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-molecular-pharmagroup-llc-2025-08-11-3014413265},
note = {Accessed: July 15, 2026}
}