Speciality Pharma Manufacturing, LLC
Form 483 issued April 8, 2025 · Carlstadt, New Jersey
- Inspection
- Apr 1 – Apr 8, 2025
- Investigators
- Catherine O. Lamptey· Syeda N. Mahazabin
- Observations
- 7
- Pages
- 6
- FEI number
- 3015282703
In short: On April 8, 2025, FDA issued a Form 483 with 7 observations to Speciality Pharma Manufacturing, LLC in Carlstadt, New Jersey (FEI 3015282703) after an inspection that ran Apr 1 – Apr 8, 2025. The investigators were Catherine O. Lamptey and Syeda N. Mahazabin. Most observations concern laboratory controls and production.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
BUPLOYEEIG) SIGNATURE. Your firm failed to establish adequate written procedures for production and process controls designed…
- 03
SRUPLOYEE(S) SIGNATURE Time limits are not established when appropriate for the completion of each production phase…
- 04
There is no written assessment of stability of homeopathic drug products based at least on testing…
This inspection in context
Catherine O. Lamptey
3 documents · 2024–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New Jersey.
The firmSpeciality Pharma Manufacturing, 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 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Speciality Pharma Manufacturing, LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Speciality Pharma Manufacturing, LLC?
Catherine O. Lamptey and Syeda N. Mahazabin are named on this Form 483, for the inspection of Apr 1 – Apr 8, 2025. Each investigator has a profile showing what they cite most.
When was Speciality Pharma Manufacturing, LLC inspected by FDA?
The inspection ran Apr 1 – Apr 8, 2025, and the Form 483 is dated April 8, 2025.
How do I get the full Form 483 for Speciality Pharma Manufacturing, 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.