Speciality Pharma Manufacturing, LLC
Form 483 issued March 16, 2020 · Carlstadt, New Jersey
- Inspection
- Mar 11 – Mar 16, 2020
- Investigator
- Jogy George
- Observations
- 1
- Pages
- 2
- FEI number
- 3015282703
In short: On March 16, 2020, FDA issued a Form 483 with 1 observation to Speciality Pharma Manufacturing, LLC in Carlstadt, New Jersey (FEI 3015282703) after an inspection that ran Mar 11 – Mar 16, 2020. The investigator was Jogy George. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Jogy George
15 documents · 2016–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in India.
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Speciality Pharma Manufacturing, LLC?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Speciality Pharma Manufacturing, LLC?
Jogy George is named on this Form 483, for the inspection of Mar 11 – Mar 16, 2020. Each investigator has a profile showing what they cite most.
When was Speciality Pharma Manufacturing, LLC inspected by FDA?
The inspection ran Mar 11 – Mar 16, 2020, and the Form 483 is dated March 16, 2020.
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.