FDA Intel

Delsam Pharma LLC

Form 483 issued March 24, 2023 · Bronx, New York

Inspection
Mar 6 – Mar 24, 2023
Investigator
Mindy M. Chou
Observations
5
Pages
4
FEI number
3018035065

In short: On March 24, 2023, FDA issued a Form 483 with 5 observations to Delsam Pharma LLC in Bronx, New York (FEI 3018035065) after an inspection that ran Mar 6 – Mar 24, 2023. The investigator was Mindy M. Chou. Most observations concern quality system and materials.

At a glance

3 of 5 observations on this 483 concern quality system.

Quality system3
Materials2

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.22(a)

    There is no quality…

  2. 02
    21 CFR 211.142(b)

    Drug products are not stored under appropriate conditions of temperature and humidity so that their identity…

  3. 03
    21 CFR 211.198(a)

    Procedures describing the handling of all written and oral complaints regarding a drug…

  4. 04
    21 CFR 211.150(b)

    A system by which the distribution of each lot of drug product can be readily determined…

1 more observation

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

Get the full 483

This inspection in context

The investigator

Mindy M. Chou

37 documents · 2015–2026

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.

The firm

Delsam Pharma LLC history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.22(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Delsam Pharma LLC?

FDA listed 5 observations on this Form 483, mostly about quality system and materials. The opening words of each observation are shown on this page.

Who inspected Delsam Pharma LLC?

Mindy M. Chou is named on this Form 483, for the inspection of Mar 6 – Mar 24, 2023. Each investigator has a profile showing what they cite most.

When was Delsam Pharma LLC inspected by FDA?

The inspection ran Mar 6 – Mar 24, 2023, and the Form 483 is dated March 24, 2023.

How do I get the full Form 483 for Delsam Pharma LLC?

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