Pharmalucence, Inc
FDA inspection history in Billerica, Massachusetts, 2017 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2019: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s, at Billerica, Massachusetts.
- 2025One Form 483, at Billerica, Massachusetts.
- 2025The longest 483 on file: 9 observations over 12 pages at Billerica, Massachusetts.
Cited most
Across all Pharmalucence observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.122(d)Materials examination and usage criteria1
The complete Pharmalucence file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Billerica, Massachusetts
Three Form 483s · 2017 to 2025 · 16 observations
Latest: Form 483, Apr 18, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-04-18 | 483 Form 483 | Billerica, Massachusetts | 9 | $99 |
| 2019-12-23 | 483 Form 483 | Billerica, Massachusetts | 4 | $99 |
| 2017-11-13 | 483 Form 483 | Billerica, Massachusetts | 3 | $99 |
Investigators on these documents
Erik W. Koester (2)Robert J. Martin (2)Armen H. Youssoufian (1)Daniel L. Zheng (1)
FEI number 3009395771 · most recent document Apr 18, 2025
About Pharmalucence, Inc
How many FDA Form 483s has Pharmalucence, Inc received?
FDA Intel has 3 Form 483s on file for Pharmalucence, Inc; the most recent is dated Apr 18, 2025.
When was Pharmalucence, Inc last inspected by FDA?
The most recent FDA inspection document on file for Pharmalucence, Inc is a Form 483 dated Apr 18, 2025, for the site in Billerica, Massachusetts.
What did FDA cite at Pharmalucence, Inc?
The regulations cited most in the observations on file for Pharmalucence, Inc are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times.