FDA Intel

Omega & Delta Co. Inc.

Form 483 issued October 23, 2023 · Carolina, Puerto Rico

Inspection
Oct 16 – Oct 23, 2023
Investigators
Alan A. Rivera· Marian E. Ramirez
Observations
3
Pages
7
FEI number
2650091

In short: On October 23, 2023, FDA issued a Form 483 with 3 observations to Omega & Delta Co. Inc. in Carolina, Puerto Rico (FEI 2650091) after an inspection that ran Oct 16 – Oct 23, 2023. The investigators were Alan A. Rivera and Marian E. Ramirez. Most observations concern quality system and production.

At a glance

Quality system and production account for 2 of 3 observations.

Quality system1
Production1
Laboratory controls1

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 211.100(a)

    Your firm failed to establish adequate written procedures for production and process controls designed to assure…

  3. 03
    21 CFR 211.166(a)

    The written stability testing…

The full 483

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

Get the full 483

This inspection in context

The investigator

Alan A. Rivera

16 documents · 2022–2026

Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.

The firm

Omega & Delta Co. Inc. history

All 3 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 Omega & Delta Co. Inc.?

FDA listed 3 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 Omega & Delta Co. Inc.?

Alan A. Rivera and Marian E. Ramirez are named on this Form 483, for the inspection of Oct 16 – Oct 23, 2023. Each investigator has a profile showing what they cite most.

When was Omega & Delta Co. Inc. inspected by FDA?

The inspection ran Oct 16 – Oct 23, 2023, and the Form 483 is dated October 23, 2023.

How do I get the full Form 483 for Omega & Delta Co. 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.

$99Get it free