Pharmalucence, Inc
Form 483 issued April 18, 2025 · Billerica, Massachusetts
- Inspection
- Mar 24 – Apr 18, 2025
- Investigators
- Armen H. Youssoufian· Daniel L. Zheng
- Observations
- 9
- Pages
- 12
- FEI number
- 3009395771
In short: On April 18, 2025, FDA issued a Form 483 with 9 observations to Pharmalucence, Inc in Billerica, Massachusetts (FEI 3009395771) after an inspection that ran Mar 24 – Apr 18, 2025. The investigators were Armen H. Youssoufian and Daniel L. Zheng. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 7 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
- 03
Written production and process control procedures are not followed in the execution of production…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Armen H. Youssoufian
9 documents · 2023–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmPharmalucence, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmalucence, Inc?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Pharmalucence, Inc?
Armen H. Youssoufian and Daniel L. Zheng are named on this Form 483, for the inspection of Mar 24 – Apr 18, 2025. Each investigator has a profile showing what they cite most.
When was Pharmalucence, Inc inspected by FDA?
The inspection ran Mar 24 – Apr 18, 2025, and the Form 483 is dated April 18, 2025.
How do I get the full Form 483 for Pharmalucence, Inc?
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.