MANA PRODUCTS, INC.

Form 483 issued October 17, 2022 · Long Island City, New York

Inspection
Oct 11 – Oct 17, 2022
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.

Quality system2
Laboratory controls1

What FDA observed

Preview: the opening words of each observation
  1. 01

    Written records of investigations into unexplained discrepancies do not always include…

  2. 02

    The calibration of instruments is not done at suitable intervals in accordance with…

  3. 03

    The responsibilities and procedures applicable to the quality control unit…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

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.?

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