Omega & Delta Co. Inc.
Form 483 issued May 6, 2022 · Carolina, Puerto Rico
- Inspection
- Apr 25 – May 6, 2022
- Investigators
- Angelica M. Hernandez· Marian E. Ramirez
- Observations
- 10
- Pages
- 15
- FEI number
- 2650091
In short: On May 6, 2022, FDA issued a Form 483 with 10 observations to Omega & Delta Co. Inc. in Carolina, Puerto Rico (FEI 2650091) after an inspection that ran Apr 25 – May 6, 2022. The investigators were Angelica M. Hernandez and Marian E. Ramirez. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
There is no quality…
- 03
EMPLOVEE(S) SIGNATURE Dare wove The identity of each component of a drug product is not verified…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Angelica M. Hernandez
15 documents · 2022–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmOmega & Delta Co. Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Omega & Delta Co. Inc.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Omega & Delta Co. Inc.?
Angelica M. Hernandez and Marian E. Ramirez are named on this Form 483, for the inspection of Apr 25 – May 6, 2022. Each investigator has a profile showing what they cite most.
When was Omega & Delta Co. Inc. inspected by FDA?
The inspection ran Apr 25 – May 6, 2022, and the Form 483 is dated May 6, 2022.
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.