Deepwater Chemicals, Inc.
Form 483 issued February 14, 2025 · Woodward, Oklahoma
- Inspection
- Feb 11 – Feb 14, 2025
- Investigators
- Margaret M. Annes· Megan Ziegler· Myarsonet M. Qunos
- Observations
- 5
- Pages
- 5
- FEI number
- 2013633
In short: On February 14, 2025, FDA issued a Form 483 with 5 observations to Deepwater Chemicals, Inc. in Woodward, Oklahoma (FEI 2013633) after an inspection that ran Feb 11 – Feb 14, 2025. The investigators were Margaret M. Annes, Megan Ziegler and Myarsonet M. Qunos. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in writing…
- 02
No unique lot number is assigned to the Iodine, USP product each time it is re-packaged…
- 03
Failure to design an adequate documented, on-going stability testing program to monitor the stability characteristics of…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmDeepwater Chemicals, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Deepwater Chemicals, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Deepwater Chemicals, Inc.?
Margaret M. Annes, Megan Ziegler and Myarsonet M. Qunos are named on this Form 483, for the inspection of Feb 11 – Feb 14, 2025. Each investigator has a profile showing what they cite most.
When was Deepwater Chemicals, Inc. inspected by FDA?
The inspection ran Feb 11 – Feb 14, 2025, and the Form 483 is dated February 14, 2025.
How do I get the full Form 483 for Deepwater Chemicals, 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.