Speciality Pharma Manufacturing, LLC
FDA inspection history in Carlstadt, New Jersey, 2020 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Carlstadt, New Jersey.
- 2025One Form 483, at Carlstadt, New Jersey.
- 2025The longest 483 on file: 7 observations over 6 pages at Carlstadt, New Jersey.
Cited most
Across all Speciality Pharma Manufacturing observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(c)(1)Stability testing1
- 21 CFR 211.63Equipment design, size, and location1
The complete Speciality Pharma Manufacturing file.
All 2 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
Carlstadt, New Jersey
Two Form 483s · 2020 to 2025 · 8 observations
Latest: Form 483, Apr 8, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-04-08 | 483 Form 483 | Carlstadt, New Jersey | 7 | $99 |
| 2020-03-16 | 483 Form 483 | Carlstadt, New Jersey | 1 | $99 |
Investigators on these documents
Catherine O. Lamptey (1)Jogy George (1)Syeda N. Mahazabin (1)
FEI number 3015282703 · most recent document Apr 8, 2025
About Speciality Pharma Manufacturing, LLC
How many FDA Form 483s has Speciality Pharma Manufacturing, LLC received?
FDA Intel has 2 Form 483s on file for Speciality Pharma Manufacturing, LLC; the most recent is dated Apr 8, 2025.
When was Speciality Pharma Manufacturing, LLC last inspected by FDA?
The most recent FDA inspection document on file for Speciality Pharma Manufacturing, LLC is a Form 483 dated Apr 8, 2025, for the site in Carlstadt, New Jersey.
What did FDA cite at Speciality Pharma Manufacturing, LLC?
The regulations cited most in the observations on file for Speciality Pharma Manufacturing, LLC are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.111 (Time limitations on production), 1 time; 21 CFR 211.165(a) (Testing and release for distribution), 1 time.