DOH Central Pharmacy
Form 483 issued July 28, 2025 · Tallahassee, Florida
- Inspection
- Jul 9 – Jul 28, 2025
- Investigator
- Dorothy P. Kramer
- Observations
- 6
- Pages
- 7
- FEI number
- 1036356
In short: On July 28, 2025, FDA issued a Form 483 with 6 observations to DOH Central Pharmacy in Tallahassee, Florida (FEI 1036356) after an inspection that ran Jul 9 – Jul 28, 2025. The investigator was Dorothy P. Kramer. Most observations concern quality system and packaging & labeling.
At a glance
Quality system and packaging & labeling account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Written records of major equipment cleaning and use are not included…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 04
Reserve drug product samples are not representative of each kit or batch of drug product and…
This inspection in context
Dorothy P. Kramer
9 documents · 2022–2025
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmDOH Central Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DOH Central Pharmacy?
FDA listed 6 observations on this Form 483, mostly about quality system, packaging & labeling and laboratory controls. The opening words of each observation are shown on this page.
Who inspected DOH Central Pharmacy?
Dorothy P. Kramer is named on this Form 483, for the inspection of Jul 9 – Jul 28, 2025. Each investigator has a profile showing what they cite most.
When was DOH Central Pharmacy inspected by FDA?
The inspection ran Jul 9 – Jul 28, 2025, and the Form 483 is dated July 28, 2025.
How do I get the full Form 483 for DOH Central Pharmacy?
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.