Asept Pak Inc
Form 483 issued April 21, 2016 · Malone, New York
- Inspection
- Apr 11 – Apr 21, 2016
- Investigator
- Helen B. Ricalde
- Observations
- 4
- Pages
- 4
- FEI number
- 3007177643
In short: On April 21, 2016, FDA issued a Form 483 with 4 observations to Asept Pak Inc in Malone, New York (FEI 3007177643) after an inspection that ran Apr 11 – Apr 21, 2016. The investigator was Helen B. Ricalde. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Production & process controls and capa account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to control environmental conditions have…
- 02
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect…
- 03
Corrective and preventive action activities and/or results have…
- 04
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
This inspection in context
Helen B. Ricalde
9 documents · 2003–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
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 820.70(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Asept Pak Inc?
FDA listed 4 observations on this Form 483, mostly about production & process controls, cAPA and packaging & labeling. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Asept Pak Inc?
Helen B. Ricalde is named on this Form 483, for the inspection of Apr 11 – Apr 21, 2016. Each investigator has a profile showing what they cite most.
When was Asept Pak Inc inspected by FDA?
The inspection ran Apr 11 – Apr 21, 2016, and the Form 483 is dated April 21, 2016.
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.