Savings Distributors LLC
Form 483 issued August 27, 2020 · Islandia, New York
- Inspection
- Aug 24 – Aug 27, 2020
- Investigator
- Bijoy Panicker
- Observations
- 9
- Pages
- 8
- FEI number
- 3011497486
In short: On August 27, 2020, FDA issued a Form 483 with 9 observations to Savings Distributors LLC in Islandia, New York (FEI 3011497486) after an inspection that ran Aug 24 – Aug 27, 2020. The investigator was Bijoy Panicker. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Employees engaged in the packing and holding of a drug product lack the required to…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmSavings Distributors LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Savings Distributors LLC?
FDA listed 9 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Savings Distributors LLC?
Bijoy Panicker is named on this Form 483, for the inspection of Aug 24 – Aug 27, 2020. Each investigator has a profile showing what they cite most.
When was Savings Distributors LLC inspected by FDA?
The inspection ran Aug 24 – Aug 27, 2020, and the Form 483 is dated August 27, 2020.
How do I get the full Form 483 for Savings Distributors 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.