Pharmco Laboratories Inc.
Amended 483 issued March 20, 2025 · Titusville, Florida
- Inspection
- Mar 13 – Mar 20, 2025
- Investigators
- Damaris Y. Hernandez· Michael Z. Weigman
- Observations
- 6
- Pages
- 32
- FEI number
- 1048788
In short: On March 20, 2025, FDA issued a Amended 483 with 6 observations to Pharmco Laboratories Inc. in Titusville, Florida (FEI 1048788) after an inspection that ran Mar 13 – Mar 20, 2025. The investigators were Damaris Y. Hernandez and Michael Z. Weigman. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug product production and control records, are not reviewed by the quality control unit to determine…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards,sampling plans and…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including…
2 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Damaris Y. Hernandez
17 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmPharmco Laboratories Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Pharmco Laboratories Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Pharmco Laboratories Inc.?
Damaris Y. Hernandez and Michael Z. Weigman are named on this Amended 483, for the inspection of Mar 13 – Mar 20, 2025. Each investigator has a profile showing what they cite most.
When was Pharmco Laboratories Inc. inspected by FDA?
The inspection ran Mar 13 – Mar 20, 2025, and the Amended 483 is dated March 20, 2025.
How do I get the full Amended 483 for Pharmco 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.