Lato Drug Company, Inc. d.b.a. Post Haste Pharmacy
Form 483 issued February 20, 2020 · Hollywood, Florida
- Inspection
- Feb 12 – Feb 20, 2020
- Investigators
- Ileana Barreto-Pettit· Joanne E. King
- Observations
- 3
- Pages
- 2
- FEI number
- 3004709093
In short: On February 20, 2020, FDA issued a Form 483 with 3 observations to Lato Drug Company, Inc. d.b.a. Post Haste Pharmacy in Hollywood, Florida (FEI 3004709093) after an inspection that ran Feb 12 – Feb 20, 2020. The investigators were Ileana Barreto-Pettit and Joanne E. King. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
3 of 3 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165 (2×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Ileana Barreto-Pettit
25 documents · 2001–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmLato Drug Company, Inc. d.b.a. Post Haste Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lato Drug Company, Inc. d.b.a. Post Haste Pharmacy?
FDA listed 3 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Lato Drug Company, Inc. d.b.a. Post Haste Pharmacy?
Ileana Barreto-Pettit and Joanne E. King are named on this Form 483, for the inspection of Feb 12 – Feb 20, 2020. Each investigator has a profile showing what they cite most.
When was Lato Drug Company, Inc. d.b.a. Post Haste Pharmacy inspected by FDA?
The inspection ran Feb 12 – Feb 20, 2020, and the Form 483 is dated February 20, 2020.
How do I get the full Form 483 for Lato Drug Company, Inc. d.b.a. Post Haste 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.