Asept Pak Inc
Form 483 issued December 20, 2019 · Malone, New York
- Inspection
- Dec 11 – Dec 20, 2019
- Investigator
- Rajiv R. Srivastava
- Observations
- 7
- Pages
- 7
- FEI number
- 3007177643
In short: On December 20, 2019, FDA issued a Form 483 with 7 observations to Asept Pak Inc in Malone, New York (FEI 3007177643) after an inspection that ran Dec 11 – Dec 20, 2019. The investigator was Rajiv R. Srivastava. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Procedures designed to prevent microbiological contamination of ding products purporting to be…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 04
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAsept Pak Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Asept Pak Inc?
FDA listed 7 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Asept Pak Inc?
Rajiv R. Srivastava is named on this Form 483, for the inspection of Dec 11 – Dec 20, 2019. Each investigator has a profile showing what they cite most.
When was Asept Pak Inc inspected by FDA?
The inspection ran Dec 11 – Dec 20, 2019, and the Form 483 is dated December 20, 2019.
How do I get the full Form 483 for Asept Pak 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.