Omega & Delta Co. Inc.
FDA inspection history in Carolina, Puerto Rico, 2022 to 2023
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2022: one warning letter and one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23Two Form 483s and one warning letter, at Carolina, Puerto Rico.
- 2022The longest 483 on file: 10 observations over 15 pages at Carolina, Puerto Rico.
Cited most
Across all Omega & Delta Co. observations on file
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.166(a)Stability testing2
- 21 CFR 211.22(a)Responsibilities of quality control unit2
- 21 CFR 211.113(a)Control of microbiological contamination1
- 21 CFR 211.192Production record review1
The complete Omega & Delta Co. file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Carolina, Puerto Rico
Two Form 483s and one warning letter · 2022 to 2023 · 13 observations
Latest: Form 483, Oct 23, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-23 | 483 Form 483 | Carolina, Puerto Rico | 3 | $99 |
| 2022-11-02 | Warning letter Warning letter | Carolina, Puerto Rico | — | $99 |
| 2022-05-06 | 483 Form 483 | Carolina, Puerto Rico | 10 | $99 |
Investigators on these documents
Marian E. Ramirez (2)Alan A. Rivera (1)Angelica M. Hernandez (1)
FEI number 2650091 · most recent document Oct 23, 2023
About Omega & Delta Co. Inc.
How many FDA Form 483s has Omega & Delta Co. Inc. received?
FDA Intel has 2 Form 483s on file for Omega & Delta Co. Inc.; the most recent is dated Oct 23, 2023.
When was Omega & Delta Co. Inc. last inspected by FDA?
The most recent FDA inspection document on file for Omega & Delta Co. Inc. is a Form 483 dated Oct 23, 2023, for the site in Carolina, Puerto Rico.
What did FDA cite at Omega & Delta Co. Inc.?
The regulations cited most in the observations on file for Omega & Delta Co. Inc. are 21 CFR 211.100(a) (Written procedures; deviations), 2 times; 21 CFR 211.166(a) (Stability testing), 2 times; 21 CFR 211.22(a) (Responsibilities of quality control unit), 2 times.
Has Omega & Delta Co. Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Omega & Delta Co. Inc.; the most recent is dated Nov 2, 2022.