MANA PRODUCTS, INC.
Form 483 issued October 17, 2022 · Long Island City, New York
- Inspection
- Oct 11 – Oct 17, 2022
- Investigators
- Syeda N. Mahazabin· Tanya R. Syffrard· Vivin George
- Observations
- 3
- Pages
- 5
- FEI number
- 2430738
In short: On October 17, 2022, FDA issued a Form 483 with 3 observations to MANA PRODUCTS, INC. in Long Island City, New York (FEI 2430738) after an inspection that ran Oct 11 – Oct 17, 2022. The investigators were Syeda N. Mahazabin, Tanya R. Syffrard and Vivin George. Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
The calibration of instruments is not done at suitable intervals in accordance with…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Syeda N. Mahazabin
19 documents · 2006–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmMANA PRODUCTS, INC. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MANA PRODUCTS, INC.?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected MANA PRODUCTS, INC.?
Syeda N. Mahazabin, Tanya R. Syffrard and Vivin George are named on this Form 483, for the inspection of Oct 11 – Oct 17, 2022. Each investigator has a profile showing what they cite most.
When was MANA PRODUCTS, INC. inspected by FDA?
The inspection ran Oct 11 – Oct 17, 2022, and the Form 483 is dated October 17, 2022.
How do I get the full Form 483 for MANA PRODUCTS, 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.