Dee Cee Laboratories, Inc
Form 483 issued August 11, 2025 · White House, Tennessee
- Inspection
- Aug 4 – Aug 11, 2025
- Investigators
- Inga M. Warr· Nelson N. Ayangho· Tomika Crafter
- Observations
- 7
- Pages
- 8
- FEI number
- 1023013
In short: On August 11, 2025, FDA issued a Form 483 with 7 observations to Dee Cee Laboratories, Inc in White House, Tennessee (FEI 1023013) after an inspection that ran Aug 4 – Aug 11, 2025. The investigators were Inga M. Warr, Nelson N. Ayangho and Tomika Crafter. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.110(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality ccmtrol unit are not in writing and fully…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
Written procedures for cleaning and maintenance fail to include assignment of responsibility, maintenance and cleaning schedules…
- 04
There is no written assessment of stability of homeopathic drug products based at least on testing…
This inspection in context
Inga M. Warr
4 documents · 2024–2025
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Tennessee.
The firmDee Cee Laboratories, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dee Cee Laboratories, Inc?
FDA listed 7 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Dee Cee Laboratories, Inc?
Inga M. Warr, Nelson N. Ayangho and Tomika Crafter are named on this Form 483, for the inspection of Aug 4 – Aug 11, 2025. Each investigator has a profile showing what they cite most.
When was Dee Cee Laboratories, Inc inspected by FDA?
The inspection ran Aug 4 – Aug 11, 2025, and the Form 483 is dated August 11, 2025.
How do I get the full Form 483 for Dee Cee Laboratories, 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.