FDA Intel

Pharmco Laboratories Inc.

Form 483 issued March 20, 2025 · Titusville, Florida

Inspection
Mar 13 – Mar 20, 2025
Investigators
Damaris Y. Hernandez· Michael Z. Weigman
Observations
6
Pages
31
FEI number
1048788

In short: On March 20, 2025, FDA issued a Form 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.

Quality system2
Facilities & equipment2
Laboratory controls1
Materials1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.192

    Drug product production and control records, are not reviewed by the quality control unit to determine…

  2. 02
    21 CFR 211.160(b)

    Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…

  3. 03
    21 CFR 211.63

    Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…

  4. 04
    21 CFR 211.67(b)(2)

    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 483

This inspection in context

The investigator

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 firm

Pharmco Laboratories Inc. history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.192

See how FDA wrote the same problem up elsewhere.

Questions about this 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 Form 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 Form 483 is dated March 20, 2025.

How do I get the full Form 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.

$99Get it free