Molecular PharmaGroup LLC
Form 483 issued August 11, 2025 · New Providence, New Jersey
- Inspection
- Jul 28 – Aug 11, 2025
- Investigators
- Amatul H. Marium· Annet R. Rajan· Stephenie M. Ortiz
- Observations
- 3
- Pages
- 5
- FEI number
- 3014413265
In short: On August 11, 2025, FDA issued a Form 483 with 3 observations to Molecular PharmaGroup LLC in New Providence, New Jersey (FEI 3014413265) after an inspection that ran Jul 28 – Aug 11, 2025. The investigators were Amatul H. Marium, Annet R. Rajan and Stephenie M. Ortiz. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Written procedures are not established for evaluations conducted at least annually to review records associated with…
This inspection in context
Amatul H. Marium
8 documents · 2022–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New York.
The firmMolecular PharmaGroup LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(vi)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Molecular PharmaGroup LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Molecular PharmaGroup LLC?
Amatul H. Marium, Annet R. Rajan and Stephenie M. Ortiz are named on this Form 483, for the inspection of Jul 28 – Aug 11, 2025. Each investigator has a profile showing what they cite most.
When was Molecular PharmaGroup LLC inspected by FDA?
The inspection ran Jul 28 – Aug 11, 2025, and the Form 483 is dated August 11, 2025.
How do I get the full Form 483 for Molecular PharmaGroup LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.